FDA Adverse Event
Injury
Summary report: N
ASR UNI FEMORAL IMPL SIZE 49
MDR report key: 2863071
·
Received December 10, 2012
Report
- Report Number
- 1818910-2012-26214
- Event Type
- Injury
- Date Received
- December 10, 2012
- Date of Event
- October 18, 2008
- Report Date
- August 23, 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. 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
LITIGATION PAPERS RECEIVED ALLEGE THAT THE PATIENT SUFFERED PAIN IN HIS HIP WHICH WORSENED AND PREVENTED HIM FROM WEIGHT BEARING AND ELEVATED LEVELS OF COBALT AND CHROMIUM IN HIS BLOOD AS A RESULT OF THE IMPLANTATION WITH THE ASR HIP IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR UNI FEMORAL IMPL SIZE 49 | FEMORAL HEAD HIP IMPLANT | KWA | DEPUY INTERNATIONAL | 2391774 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |