FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY ASR CUP
MDR report key: 2122771
·
Received June 3, 2011
Report
- Report Number
- 1818910-2011-09831
- Event Type
- Injury
- Date Received
- June 3, 2011
- Date of Event
- May 4, 2011
- Report Date
- May 5, 2011
- Manufacturer
- DEPUY INTL., LTD.
- Product Code
- KWA
- PMA / PMN Number
- NA
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
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).
Description of Event or Problem · 1
THE PT WAS REVISED TO ADDRESS INFECTION AND ALVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY ASR CUP | 87KWA | KWA | DEPUY INTL., LTD. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |