FDA Adverse Event
Injury
Summary report: N
DEPUY ASR FEM IMPLANT SZ 51
MDR report key: 2033697
·
Received March 17, 2011
Report
- Report Number
- 1818910-2011-04198
- Event Type
- Injury
- Date Received
- March 17, 2011
- Date of Event
- January 4, 2011
- Report Date
- February 15, 2011
- Manufacturer
- DEPUY INTERNATIONAL, LTD
- Product Code
- KXA
- PMA / PMN Number
- K032659
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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.
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.
Description of Event or Problem · 1
THE RIGHT HIP WAS REVISED TO ADDRESS ACETABULAR LOOSENING, PAIN AND ELEVATED METAL ION LEVELS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEPUY ASR FEM IMPLANT SZ 51 | 87KXA | KXA | DEPUY INTERNATIONAL, LTD | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |