FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY ASR CUP
MDR report key: 2895121
·
Received January 3, 2013
Report
- Report Number
- 1818910-2012-26965
- Event Type
- Injury
- Date Received
- January 3, 2013
- Date of Event
- August 1, 2012
- Report Date
- November 26, 2012
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KWA
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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. (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
USER FACILITY REPORTED INCREASING PAIN, FLUID COLLECTION, AND HIGH LEVELS OF COBALT CHROMIUM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3353 | UNKNOWN DEPUY ASR CUP | ACETABULAR CUP | KWA | DEPUY INTERNATIONAL | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |