FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY ASR FEMORAL CUP
MDR report key: 3200627
·
Received July 1, 2013
Report
- Report Number
- 1818910-2013-20291
- Event Type
- Injury
- Date Received
- July 1, 2013
- Date of Event
- June 27, 2013
- Report Date
- June 27, 2013
- Manufacturer
- DEPUY INTL., LTD. - 8010379
- Product Code
- KXA
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, 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
PATIENT UNDERWENT REVISION PROCEDURE OF RIGHT HIP DUE TO UNKNOWN REASONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 298091 | UNKNOWN DEPUY ASR FEMORAL CUP | FEMORAL HEAD | KXA | DEPUY INTL., LTD. - 8010379 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |