DePuy Orthopaedics, Inc.: DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM¿ Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the; DePuy Orthopaedics has identified the potential for holes to develop in th

Agency Publication Date: March 13, 2014

Affected Products

Product: REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral an

249649, 102928, 102929, 109312, 128472, 142839, 142840, 142841, 162485, 196050, 196051, 196052, 211382, 211387, 213581, 227387, 231687, 249644, 249647, 269701, 269702, 288346, 298769, 298770, 298772, 306503, 306505, 329328, 338142, 346434, 354575, 360633, 360634, 366429, 366430, 373254, 378641, 378642, 378644, 402462, 403004, 403005, 403007, 403008, 421300, 438246, 438247, 438248, 438249, 452447, 456738, 456740, 466369, 466370, 466371, 058401LA, 137401LA, D2WBG4, D37FW4, D37GP4, DV6LY4, DY5EC4, DY5ED4, E1VHM4, E3SDW4, E6CE94, E82E14, EA8EH4, EF5BS4, EJ6G34, EW6HT4, FJ3D14, FJ3D24, and FJ3DY4

Product: REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral a

102325, 102326, 109315, 109316, 120082, 128475, 142843, 142845, 162487, 197812, 197813, 197814, 207924, 222654, 222657, 231689, 231690, 236435, 236442, 261758, 265711, 265714, 265715, 265717, 282997, 285154, 285155, 289096, 302804, 302807, 302808, 317754, 317755, 338154, 338155, 338157, 354580, 360635, 360636, 366432, 378645, 378647, 378650, 400505, 400506, 402456, 414735, 414736, 414737, 430481, 451998, 451999, 452448, 456741, 456742, 456743, 472193, 472194, 472195, 197401RA, D2WBJ4, DY5EF4, E3SD14, E49HN4, EW6HW4, EW6HX4, and FK8CR4

Product: REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and

E1VHS4, 430482, 338164, 373256, 395802, 409578, 448220, 409582, 238688, 430483, 306508, 329330, 264451, 448222, 216275, 373255, 346439, 409580, 338165, 250929, 360638, D65FJ4, 216277, 395804, EJ7F14, 254740, 302815, FF8DW4, 314821, 464642, 338166, FA4FP4, FA4FT4, 238411LC, 464643, 278448, 409579, 464640, 395803, 088411LA, 308248, FF8DX4, 196411LA, 448227, C1VCE4, 402352, 346437, 366433, 238687, 172188, 329332, 250931, 464641, 216274, 302813, 295384, 264453, 337411LA, 120084, 236445, 289043, 329331, 308247, and 395806

Product: REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and

102932, 102933, 102934, 120086, 142854, 156155, 156156, 156157, 162493, 172189, 181460, 181462, 193663, 231692, 231695, 236448, 241369, 241371, 246794, 261763, 269712, 278450, 278451, 278452, 282999, 283000, 283001, 291033, 291034, 302817, 306511, 306512, 306513, 317757, 317758, 329334, 338167, 338168, 346440, 360639, 360640, 360641, 366434, 366435, 366436, 378652, 392023, 400513, 400514, 406837, 409583, 412683, 414752, 430490, 430491, 430492, 448537, 456744, 456745, 456747, 456748, 464644, 464646, 464647, 266411RA, 467411RB, D1TAN4, E1VHX4, E4EGB4, E73H74, E82E74, E82E84, E82E94, EN7JC4, EW6H24, FK8GP4, and FL1VH4.

Product: REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral a

Both left and Right 102935, 110571, 114271, 114274, 114277, 128477, 132946, 142857, 156158, 162498, 162499, 162500, 172191, 172194, 193664, 193668, 217297, 224704, 229189, 229192, 229195, 229196, 236454, 236463, 236466, 241379, 249713, 249714, 249715, 254742, 254743, 260549, 260552, 269715, 269717, 278454, 278456, 283005, 283006, 283007, 291037, 291038, 291039, 295391, 302819, 306516, 306517, 314828, 314831, 314832, 317759, 317761, 317765, 317769, 317770, 317772, 329335, 338170, 338171, 338173, 338176, 346442, 354609, 354614, 360644, 360645, 360646, 360647, 366437, 366439, 366440, 373257, 373258, 378654, 378655, 378657, 378660, 385029, 385031, 385033, 385034, 392028, 392029, 392032, 400543, 400544, 402441, 403009, 403012, 409586, 414761, 414762, 414763, 414764, 414765, 414766, 414767, 430493, 430494, 430495, 430496, 430498, 438592, 438593, 438594, 438595, 438596, 438597, 438598, 438599, 448539, 452452, 453170, 453171, 453172, 456749, 456751, 456752, 456753, 456754, 470494, 470496, 470503, 470504, D51B54, D51B64, D51B84, D51B94, DN5ET4, DY5EP4, E4EGG4, E5WCF4, E6CFK4, FD6G14, FE2DP4, FL8AM4

Product: REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral a

Both Right and Left 102935, 110571, 114271, 114274, 114277, 128477, 132946, 142857, 156158, 162498, 162499, 162500, 172191, 172194, 193664, 193668, 217297, 224704, 229189, 229192, 229195, 229196, 236454, 236463, 236466, 241379, 249713, 249714, 249715, 254742, 254743, 260549, 260552, 269715, 269717, 278454, 278456, 283005, 283006, 283007, 291037, 291038, 291039, 295391, 302819, 306516, 306517, 314828, 314831, 314832, 317759, 317761, 317765, 317769, 317770, 317772, 329335, 338170, 338171, 338173, 338176, 346442, 354609, 354614, 360644, 360645, 360646, 360647, 366437, 366439, 366440, 373257, 373258, 378654, 378655, 378657, 378660, 385029, 385031, 385033, 385034, 392028, 392029, 392032, 400543, 400544, 402441, 403009, 403012, 409586, 414761, 414762, 414763, 414764, 414765, 414766, 414767, 430493, 430494, 430495, 430496, 430498, 438592, 438593, 438594, 438595, 438596, 438597, 438598, 438599, 448539, 452452, 453170, 453171, 453172, 456749, 456751, 456752, 456753, 456754, 470494, 470496, 470503, 470504, D51B54, D51B64, D51B84, D51B94, DN5ET4, DY5EP4, E4EGG4, E5WCF4, E6CFK4, FD6G14, FE2DP4, FL8AM4

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 67627

Status: Resolved

Manufacturer: DePuy Orthopaedics, Inc.

Manufactured In: United States

Units Affected: 6 products (129; 128; 134; 137; 130; 132)

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Sources: FDA iRES · Raw API Response

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Affected Products