Zimmer, Inc.: Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Intraoperative dislodging of the provisional head and the provisional head being left in-vivo after separating from mating comp

Agency Publication Date: September 28, 2012

Affected Products

Product: 00789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femoral Head Provisional 22mm -2 00789502230 VerSys Femoral Head Provisional 22mm +3 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

All lots distributed from lot 69998600 (2/20/1996) to present

Lot Numbers:

69998600

Product: 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0 00789502603 VerSys Femoral Head Provisional 26mm +3.5 00789502604 VerSys Femoral Head Provisional 26mm +7 00789502605 VerSys Femoral Head Provisional 26mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometry y and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

All lots distributed from lot 69998600 (2/20/1996) to present

Lot Numbers:

69998600

Product: 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0 00789502803 VerSys Femoral Head Provisional 28mm +3.5 00789502804 VerSys Femoral Head Provisional 28mm +7 00789502805 VerSys Femoral Head Provisional 28mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

All lots distributed from lot 69998600 (2/20/1996) to present

Lot Numbers:

69998600

Product: 12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head Provisional 32mm +3.5 00789503204 VerSys Femoral Head Provisional 32mm +7 00789503205 VerSys Femoral Head Provisional 32mm +10.5 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

All lots distributed from lot 69998600 (2/20/1996) to present

Lot Numbers:

69998600

Product: 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head Provisional 36mm +3.5 00789503604 VerSys Femoral Head Provisional 36mm +7 00789503605 VerSys Femoral Head Provisional 36mm +10.5 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

All lots distributed from lot 69998600 (2/20/1996) to present

Lot Numbers:

69998600

Product: 12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provisional 40mm +3.5 00789504004 VerSys Femoral Head Provisional 40mm +7 00789504005 VerSys Femoral Head Provisional 40mm +10.5 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

All lots distributed from lot 69998600 (2/20/1996) to present

Lot Numbers:

69998600

Product: 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

All lots including lot 78939000 (1/7/2002) to present

Lot Numbers:

78939000

Product: 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26 00780302604 MIS 12/14 Slotted Femoral Head Provisional +7X26 00780302605 MIS 12/14 Slotted Femoral Head Provisional +10.5X26 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during

All lots including lot 78939000 (1/7/2002) to present

Lot Numbers:

78939000

Product: 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X28 00780302804 MIS 12/14 Slotted Femoral Head Provisional +7X28 00780302805 MIS 12/14 Slotted Femoral Head Provisional +10.5X28 00780302814 MIS 12/14 Slotted Femoral Head Provisional +7X28 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability,

All lots including lot 78939000 (1/7/2002) to present

Lot Numbers:

78939000

Product: 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32 00780303204 MIS 12/14 Slotted Femoral Head Provisional +7X32 00780303205 MIS 12/14 Slotted Femoral Head Provisional +10.5X32 00780303214 MIS 12/14 Slotted Femoral Head Provisional +7X32 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability,

All lots including lot 78939000 (1/7/2002) to present

Lot Numbers:

78939000

Product: 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780303604 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780303605 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during

All lots including lot 78939000 (1/7/2002) to present

Lot Numbers:

78939000

Product: 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780304005 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during

All lots including lot 78939000 (1/7/2002) to present

Lot Numbers:

78939000

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 62110

Status: Resolved

Manufacturer: Zimmer, Inc.

Manufactured In: United States

Units Affected: 12 products (231641 all sizes; 231, 641 all lots; 231,641 all lots, all sizes; 231,641 all lots, all sizes; 231,641; 231,641; 231, 641 all lots; 231,641; 231,641 all lots, all sizes; 231,641; 231,641 all lots, all sizes; 231,641 all lots, all sizes)

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Sources: FDA iRES · Raw API Response

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Affected Products

All lots distributed from lot 69998600 (2/20/1996) to present

Lot Numbers:

69998600

All lots distributed from lot 69998600 (2/20/1996) to present

Lot Numbers:

69998600

All lots distributed from lot 69998600 (2/20/1996) to present

Lot Numbers:

69998600

All lots distributed from lot 69998600 (2/20/1996) to present

Lot Numbers:

69998600

All lots distributed from lot 69998600 (2/20/1996) to present

Lot Numbers:

69998600

All lots distributed from lot 69998600 (2/20/1996) to present

Lot Numbers:

69998600

All lots including lot 78939000 (1/7/2002) to present

Lot Numbers:

78939000

All lots including lot 78939000 (1/7/2002) to present

Lot Numbers:

78939000

All lots including lot 78939000 (1/7/2002) to present

Lot Numbers:

78939000

All lots including lot 78939000 (1/7/2002) to present

Lot Numbers:

78939000

All lots including lot 78939000 (1/7/2002) to present

Lot Numbers:

78939000

All lots including lot 78939000 (1/7/2002) to present

Lot Numbers:

78939000

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 62110

Status: Resolved

Manufacturer: Zimmer, Inc.

Manufactured In: United States