FDA Adverse Event
Injury
Summary report: N
ASR ACETABULAR CUPS 58
MDR report key: 2526477
·
Received April 11, 2012
Report
- Report Number
- 1818910-2012-09738
- Event Type
- Injury
- Date Received
- April 11, 2012
- Report Date
- March 15, 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
- NY, 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.
Additional Manufacturer Narrative · 1
PMA/510(K): K040627.
Description of Event or Problem · 1
LITIGATION ALLEGES THAT PATIENT HAS PAIN, SORENESS, STIFFNESS, AND DISCOMFORT. PATIENT HAS BEEN FOUND TO HAVE ELEVATED COBALT LEVELS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR ACETABULAR CUPS 58 | TOTAL HIP REPLACEMENT | KWA | DEPUY INTERNATIONAL | 2783219 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |