FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY ASR CUP
MDR report key: 3072241
·
Received April 23, 2013
Report
- Report Number
- 1818910-2013-06726
- Event Type
- Injury
- Date Received
- April 23, 2013
- Date of Event
- April 8, 2013
- Report Date
- April 8, 2013
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KWA
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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 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 WAS REVISED DUE PAIN, DISCOMFORT AND OSTEOLYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 175627 | UNKNOWN DEPUY ASR CUP | ACETABULAR CUP | KWA | DEPUY INTERNATIONAL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |