This article is part of the Arthritis Archives.
Dateline: January 20, 2001
Sulzer Hip Implant Recall
Sulzer Orthopedics, a subsidiary of Sulzer Medica, has recalled certain lot numbers of its Inter-Op acetabular shells. Most of the recalled hip replacement products were manufactured during or after October 1999 but a limited number were produced as early as June 1997. The affected lot numbers of the Inter-Op acetabular shell included approximately 25,000 units of which 17,500 were implanted.
In September 2000, Sulzer Orthopedics of Austin, Texas, the manufacturer of the defective implant, began receiving adverse reports from doctors. Following an 8-week investigation of patient records, surgical techniques, and the product itself, the recall was ordered. It was ultimately found that during the manufacturing process a small amount of mineral oil-based lubricant leaked into the machine coolant, and even after the cleaning process, the lubricant remained as residue on the shell. No other implant manufactured by Sulzer, other than the Inter-Op acetabular shell, was affected. Since the problem was identified, steps in the manufacturing process have been either eliminated or modified to prevent a recurrence of the problem.
Designed so that the acetabular component snaps into place and bone grows into it, the oily residue interfered with the bonding. Some people who have received the defective implant have reported loosening and have required further surgery to revise the failed hip replacement. Patients who had the acetabular component cemented in place are unaffected by the recall.
Sulzer Recommendations
Although the FDA has not required it, Sulzer Orthopedics has recommended that surgeons contact patients who received the Inter-Op shells from the affected lots. To recognize if there is a problem with an Inter-Op shell implant, Sulzer recommends patients and surgeons be aware of the following symptoms:
- Sedimentation rate, C-reactive protein, and aspiration show no evidence of infection preoperatively.
- All cultures at surgery are negative and an arthrogram does not show dye around the shell.
Up to 6 weeks post-op
- The patient may be progressing well, or may be reporting pain in the groin or anterior trochanteric area.
- Patient may have increased thigh pain.
- Patient may have significant pain when starting to walk, or buttock pain after rising from seated position.
- X-ray may show possible migration of the component.
6 weeks to 3 months post-op
- Significant pain with weightbearing, possibly requiring a cane or crutch.
- Patient cannot exert resistance in straight-raised leg test or side-lying abduction test.
At 3 months post-op
- A line around the acetabular component and possible migration can be seen sometimes only on Lauenstein lateral x-ray, not AP x-rays.
Revision Surgery
Sulzer intends to reimburse patients for all out-of-pocket expenses incurred due to revision surgery, not reimbursed by insurance or Medicare. A patient hotline has been set up at 800-888-4676, ext. 232 for questions about reimbursement or additional information. To determine if you have one of the implants from the affected lot numbers, your medical records contain lot number information pertinent to your specific case.
Since the manufacturing problem has been identified and corrected, shipments of Inter-Op shells meeting strict safety criteria are expected to resume in January 2001.
Related Resources
Sources: Sulzer Orthopedics Inter-Op Voluntary Recall, sulzerortho.com; Artificial Hips Recalled, ABCNEWS.com; Hip Replacement Patients May Face More Surgery, CNN.com
First published: 1/20/2001
