FDA Adverse Event
Injury
Summary report: N
ASR ACETABULAR CUPS 58
MDR report key: 3031890
·
Received April 3, 2013
Report
- Report Number
- 1818910-2013-04346
- Event Type
- Injury
- Date Received
- April 3, 2013
- Date of Event
- February 20, 2013
- Report Date
- March 22, 2013
- 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
- PA, 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
MAUDE EVENT REPORT (B)(4) STATES: RECALLED DEPUY ASR RIGHT TOTAL HIP HARDWARE REMOVED AND REPLACED DURING HIP REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 137025 | ASR ACETABULAR CUPS 58 | ACETABULAR CUP | KWA | DEPUY INTERNATIONAL | 2123922 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |