FDA Adverse Event
Injury
Summary report: N
ASR 300 SPIKED CUP SIZE 50
MDR report key: 3171381
·
Received June 14, 2013
Report
- Report Number
- 1818910-2013-18961
- Event Type
- Injury
- Date Received
- June 14, 2013
- Date of Event
- April 17, 2013
- Report Date
- May 21, 2013
- Manufacturer
- DEPUY INTL., 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
- US
- Reporter Occupation
- PATIENT
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 CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE THAT THE PATIENT WAS REVISED TO ADDRESS ABDUCTOR WEAKNESS AND SNAPPING OF THE ILIOTIBIAL BAND. UPON REVISION CLOUDY FLUID AND METALLOSIS WAS FOUND IN THE HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271972 | ASR 300 SPIKED CUP SIZE 50 | ACETABULAR CUP | KWA | DEPUY INTL., LTD. - 8010379 | 2692785 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |