
On December 8, 2000 Sulzer Orthopedics recalled its Inter-Op acetabular shell for hip implants. These implants were sold primarily after October, 1999, with a small number of lots sold after July, 1997. About twenty thousand patients are affected by the recall.
The recall followed the reports of post-operative loosening of a number of the shells. Testing of the shells reportedly revealed a lubricant residue that was used in the manufacturing process. In some people this residue may prevent your bones from bonding with your hip implant. Loosening of the shells may recur because of this reaction.
Symptoms include pain in your inner thigh or groin, pain when arising from a seated position or pain with standing and weight bearing, if you experience any of these symptoms please call us and your surgeon. You should ask your surgeon for the specific lot number of your hip replacement, in order to determine if the hip shell you received is covered by the recall. The following information is provided to help you determine if your lot # has been recalled.
| Shell Product | Catalog Numbers | Lot Numbers Beginning # | Lot Numbers Ending # |
| Hemispherical | 4360-00-039 through 4360-00-065 |
137848 | 1456372 |
| Rim Flare | 4361-00-039 through 4361-00-071 |
1398234 | 1465247 |
| Revision | 4362-00-043 through 4362-00-081 |
1397531 | 1465242 |
| Protusio | 4363-00-053 through 4363-00-081 |
1403576 | 1453540 |
Silverman & Fodera, P.C. is actively prosecuting, individual lawsuits on behalf of persons who have received the allegedly defective product, breach of warranty, negligence and strict liability for failure to warn recipients of the defect. Damages sought against Sulzer include damages for:
If you or a loved one are the recipient of one of the Sulzer implants, call us at (800) 220-LAW1, or use the "Do I Have A Case?" link on this web site.
This informational piece was prepared by Silverman & Fodera. If you would like more information on this topic, call us at (800) 220-LAW1, or use the "Do I Have A Case?" link on this web site.