FDA Adverse Event
Injury
Summary report: N
ASR UNI FEMORAL IMPL SIZE 49
MDR report key: 4802132
·
Received May 28, 2015
Report
- Report Number
- 1818910-2015-22055
- Event Type
- Injury
- Date Received
- May 28, 2015
- Date of Event
- May 14, 2015
- Report Date
- May 14, 2015
- Manufacturer
- DEPUY INTERNATIONAL LTD.8010379
- Product Code
- KWA
- PMA / PMN Number
- PK040627
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 THIS INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. (B)(4).
Description of Event or Problem · 1
PATIENT WAS REVISED TO ADDRESS PAIN, METALOSIS, OSTEOLYSIS, AND CUP LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 344907 | ASR UNI FEMORAL IMPL SIZE 49 | HIP FEMORAL HEAD | KWA | DEPUY INTERNATIONAL LTD.8010379 | 2422433 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |