FDA Adverse Event
Injury
Summary report: N
ASR ACETABULAR IMPLANT 50
MDR report key: 3063593
·
Received April 17, 2013
Report
- Report Number
- 1818910-2013-04936
- Event Type
- Injury
- Date Received
- April 17, 2013
- Date of Event
- March 1, 2009
- Report Date
- April 9, 2013
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KWA
- Removal / Correction Number
- Z- 1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PATIENT
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. (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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.
Description of Event or Problem · 1
ASR REVISION; ASR RESURFACING - LEFT; REASON(S) FOR REVISION: NOISE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 165035 | ASR ACETABULAR IMPLANT 50 | ASR TOTAL HIP REPLACEMENT | KWA | DEPUY INTERNATIONAL | 1143078 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |