FDA Adverse Event
Injury
Summary report: N
DEPUY ASR XL FEM IMP SIZE 43
MDR report key: 3022883
·
Received March 27, 2013
Report
- Report Number
- 1818910-2013-03701
- Event Type
- Injury
- Date Received
- March 27, 2013
- Date of Event
- January 15, 2013
- Report Date
- June 27, 2013
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KWA
- 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
DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.
Additional Manufacturer Narrative · 1
THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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
ASR REVISION; ASR XL - LEFT HIP; REASON FOR REVISION: ALVAL/SOFT TISSUE REACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 126331 | DEPUY ASR XL FEM IMP SIZE 43 | ASR TOTAL HIP REPLACEMENT | KWA | DEPUY INTERNATIONAL | 2001704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |