FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY ASR HIP
MDR report key: 1943868
·
Received December 28, 2010
Report
- Report Number
- 1818910-2010-09682
- Event Type
- Injury
- Date Received
- December 28, 2010
- Report Date
- October 17, 2013
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- KWA
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
MFR 1818910-2010-09682 IS A REPORT FOR AN INVALID CLAIM, AND IS THEREFORE BEING REJECTED. PLEASE DISREGARD THE PREVIOUS REPORT.
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. REF. WWCAPA (B)(4).
Description of Event or Problem · 1
RECOMMENDED ASR REVISION.
Description of Event or Problem · 1
MFR 1818910-2010-09682 IS A REPORT FOR AN INVALID CLAIM, AND IS THEREFORE BEING REJECTED. PLEASE DISREGARD THE PREVIOUS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY ASR HIP | 87KWA | KWA | DEPUY INTERNATIONAL, LTD. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |