FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY ASR ACETABULAR CUP
MDR report key: 2791960
·
Received October 15, 2012
Report
- Report Number
- 1818910-2012-77131
- Event Type
- Injury
- Date Received
- October 15, 2012
- Report Date
- February 27, 2026
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KWA
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- ATTORNEY
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
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
LITIGATION ALLEGED THE PATIENT SUFFERED PAIN, DISCOMFORT, DECREASED RANGE OF MOTION AND LOSS OF MUSCLE MASS AND DETERIORATION OF THE BONE AND SOFT TISSUE AS A RESULT OF THE IMPLANTED ASR HIP. IN ADDITION, THE ASR HIP ALLEGEDLY EXHIBIT AUDIBLE NOISES SUCH AS SQUEAKING AND POPPING SOUNDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY ASR ACETABULAR CUP | ACETABULAR CUP HIP IMPLANT | KWA | DEPUY INTERNATIONAL | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |