FDA Adverse Event
Injury
Summary report: N
ASR ACETABULAR CUPS 52
MDR report key: 3081968
·
Received April 29, 2013
Report
- Report Number
- 1818910-2013-06752
- Event Type
- Injury
- Date Received
- April 29, 2013
- Date of Event
- April 17, 2013
- Report Date
- July 15, 2013
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KWA
- PMA / PMN Number
- K040627
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.
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 WAS REVISED DUE TO PATIENT REQUEST. ALL COMPONENTS WERE ALIGNED AND FIXED WELL.
Description of Event or Problem · 1
**UPDATE**(B)(4) 2013 - LITIGATION RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM PAIN AND EXCESSIVE LEVELS OF CHROMIUM COBALT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183268 | ASR ACETABULAR CUPS 52 | ACETABULAR CUP | KWA | DEPUY INTERNATIONAL | 2285570 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |