FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY ASR FEMORAL HEAD
MDR report key: 2801856
·
Received October 23, 2012
Report
- Report Number
- 1818910-2012-23843
- Event Type
- Injury
- Date Received
- October 23, 2012
- Report Date
- August 15, 2012
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KWA
- 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.
Description of Event or Problem · 1
LITIGATION PAPERS ALLEGE THE PATIENT SUFFERS FROM PAIN, ELEVATED METAL ION LEVELS, DISFIGUREMENT, PHYSICAL IMPAIRMENT AND EMOTIONAL STRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY ASR FEMORAL HEAD | ASR TOTAL HIP REPLACEMENT | KWA | DEPUY INTERNATIONAL | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |