FDA Adverse Event
Injury
Summary report: N
DEPUY ASR FEM IMPLANT SZ 51
MDR report key: 2920004
·
Received January 17, 2013
Report
- Report Number
- 1818910-2013-01380
- Event Type
- Injury
- Date Received
- January 17, 2013
- Report Date
- December 18, 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
- TX, 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.
Additional Manufacturer Narrative · 1
DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.
Description of Event or Problem · 1
PATIENT SEEKING LEGAL ACTION. UPDATE LITIGATION ALLEGED THE PATIENT SUFFERED PAIN, IMPAIRMENT, LIMITED RANGE OF MOTION OF THE JOINT, AND ELEVATED LEVELS OF CHROMIUM AND COBALT AS A RESULT OF THE IMPLANTED ASR HIP.
Description of Event or Problem · 1
PATIENT SEEKING LEGAL ACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27138 | DEPUY ASR FEM IMPLANT SZ 51 | FEMORAL HEAD | KWA | DEPUY INTERNATIONAL | 2333580 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |