FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN DEPUY ASR HIP
MDR report key: 2023553
·
Received March 1, 2011
Report
- Report Number
- 1818910-2011-02377
- Event Type
- Malfunction
- Date Received
- March 1, 2011
- Report Date
- January 30, 2011
- Manufacturer
- DEPUY INTL LTD
- Product Code
- KWA
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
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).
Description of Event or Problem · 1
THE PT HAS BEEN RECOMMENDED FOR AN ASR REVISION. SPECIFIC DETAILS REGARDING THE REPORT ARE UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY ASR HIP | 87KWA | KWA | DEPUY INTL LTD | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |