FDA Adverse Event
Injury
Summary report: N
DEPUY ASR XL FEM IMP SZ 49
MDR report key: 1772314
·
Received July 23, 2010
Report
- Report Number
- 1818910-2010-05133
- Event Type
- Injury
- Date Received
- July 23, 2010
- Date of Event
- May 13, 2010
- Report Date
- June 25, 2010
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- JDI
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE UNITED STATES UNDER A DIFFERENT PART NUMBER. 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. REF. (B)(4).
Description of Event or Problem · 1
PT WAS REVISED TO ADDRESS UNEXPLAINED PAIN. POOR FUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEPUY ASR XL FEM IMP SZ 49 | TOTAL HIP REPLACEMENT | JDI | DEPUY INTERNATIONAL, LTD. | NA | 2138943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |