FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY ASR FEMORAL HEAD SIZE 47
MDR report key: 4090901
·
Received September 15, 2014
Report
- Report Number
- 1818910-2014-28057
- Event Type
- Injury
- Date Received
- September 15, 2014
- Date of Event
- August 27, 2014
- Report Date
- August 27, 2014
- Manufacturer
- DEPUY INTERNATIONAL LTD.-8010379
- Product Code
- KXA
- 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. REF. (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.
Description of Event or Problem · 1
PATIENT HAS BEEN REVISED TO ADDRESS METALLOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 568459 | UNKNOWN DEPUY ASR FEMORAL HEAD SIZE 47 | HIP FEMORAL HEAD | KXA | DEPUY INTERNATIONAL LTD.-8010379 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |