FDA Adverse Event
Injury
Summary report: N
ASR ACETABULAR CUPS 54
MDR report key: 2925870
·
Received January 22, 2013
Report
- Report Number
- 1818910-2013-00336
- Event Type
- Injury
- Date Received
- January 22, 2013
- Date of Event
- June 20, 2007
- Report Date
- August 22, 2012
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KWA
- PMA / PMN Number
- K040627
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, 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). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED PAIN, NUMBNESS, TINGLING, DIFFICULTY AMBULATING AND DIFFICULTY WITH SIMPLE DAILY LIVING ACTIVITIES AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30232 | ASR ACETABULAR CUPS 54 | ACETABULAR CUP HIP IMPLANT | KWA | DEPUY INTERNATIONAL | 2160685 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |