FDA Adverse Event
Injury
Summary report: N
ASR ACETABULAR IMPLANT 52
MDR report key: 1923672
·
Received December 9, 2010
Report
- Report Number
- 1818910-2010-09186
- Event Type
- Injury
- Date Received
- December 9, 2010
- Date of Event
- November 9, 2010
- Report Date
- November 9, 2010
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- KWA
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. (B)(4).
Additional Manufacturer Narrative · 1
NO 510K# SUBMITTED AS DEPUY ORTHOPAEDICS SELLS A SIMILAR PRODUCT (OR THE SAME PRODUCT WITH A DIFFERENT PRODUCT CODE) IN THE UNITED STATES. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
CORAIL ASR REVISION HIP DUE TO PAIN AND REACTION TO METAL ON METAL BEARING. PAIN AND TISSUE REACTION FOLLOWING TOTAL HIP REPLACEMENT USING ASR METAL BEARING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR ACETABULAR IMPLANT 52 | 87KWA | KWA | DEPUY INTERNATIONAL, LTD. | NA | 1639882 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |