FDA Adverse Event
Injury
Summary report: N
ASR ACETABULAR CUPS 52
MDR report key: 2925510
·
Received January 22, 2013
Report
- Report Number
- 1818910-2013-01144
- Event Type
- Injury
- Date Received
- January 22, 2013
- Report Date
- August 22, 2012
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KWA
- PMA / PMN Number
- K040627
- Removal / Correction Number
- Z1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- ATTORNEY
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. (B)(4).
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. (B)(4).
Description of Event or Problem · 1
LITIGATION ALLEGES THAT THE PATIENT SUFFERED PAIN, STIFFNESS, DISCOMFORT, CLICKING, EXCESSIVE LEVELS OF CHROMIUM AND COBALT AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTS PLAINTIFFS MOBILITY AND QUALITY OF LIFE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30734 | ASR ACETABULAR CUPS 52 | TOTAL HIP IMPLANT | KWA | DEPUY INTERNATIONAL | 2876231 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |