FDA Adverse Event
Injury
Summary report: N
ASR ACETABULAR IMPLANT 52
MDR report key: 2071447
·
Received April 15, 2011
Report
- Report Number
- 1818910-2011-05269
- Event Type
- Injury
- Date Received
- April 15, 2011
- Report Date
- March 16, 2011
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- KWA
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
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.
Description of Event or Problem · 1
THE SUBJECT UNDERWENT PRIMARY TOTAL HIP REPLACEMENT IN (B)(6) 2006 FOR OSTEOARTHRITIS. IT WAS REPORTED IN (B)(6) 2011 THAT SPIN OUT OF THE ACETABULAR CUP HAD OCCURRED. THE INVESTIGATOR INDICATES A PROBABLE RELATIONSHIP BETWEEN THE ADVERSE EVENT AND THE FEMORAL HEAD AND ACETABULAR CUP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR ACETABULAR IMPLANT 52 | TOTAL HIP PROSTHESIS | KWA | DEPUY INTERNATIONAL, LTD. | NA | 1923567 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |