ASR ACETABULAR CUPS 50
Report
- Report Number
- 1818910-2010-06684
- Event Type
- Injury
- Date Received
- September 27, 2010
- Report Date
- September 1, 2010
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- KWA
- PMA / PMN Number
- K040627
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- UNKNOWN
Narratives
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 STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE REQUIRED PRODUCT AND LOT CODE INFO WAS NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE DUE TO INSUFFICIENT INFO. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
LEGAL CLAIM FORWARDED TO CUSTOMER QUALITY FOR REVIEW. NO OTHER INFO IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR ACETABULAR CUPS 50 | ACETABULAR CUP HIP IMPLANT | KWA | DEPUY INTERNATIONAL, LTD. | NA | 2300349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |