FDA Adverse Event
Injury
Summary report: N
ASR UNI FEMORAL IMPL SIZE 45
MDR report key: 2862206
·
Received December 7, 2012
Report
- Report Number
- 1818910-2012-27220
- Event Type
- Injury
- Date Received
- December 7, 2012
- Date of Event
- April 26, 2011
- Report Date
- April 26, 2011
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KWA
- PMA / PMN Number
- K040627
- Removal / Correction Number
- Z-1749/1816-2011
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
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. REF. (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. (B)(4).
Description of Event or Problem · 1
PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE: (B)(6) 2012 - LITIGATION PAPERS RECEIVED (B)(6) 2012. LITIGATION PAPERS ALLEGE, PATIENT SUFFERED PAIN AND SUFFERING AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT. UPDATE: (B)(6) 2012 - PATIENTS FACT SHEET WAS RECEIVED (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR UNI FEMORAL IMPL SIZE 45 | FEMORAL HEAD | KWA | DEPUY INTERNATIONAL | 2334963 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |