FDA Adverse Event
Injury
Summary report: N
ASR ACETABULAR IMPLANT 56
MDR report key: 1250710
·
Received December 2, 2008
Report
- Report Number
- 1818910-2008-05714
- Event Type
- Injury
- Date Received
- December 2, 2008
- Date of Event
- November 5, 2008
- Report Date
- November 5, 2008
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- KWB
- 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 IMPLANT IS NOT SOLD IN THE US TO BE IMPLANTED FOR THIS INDICATION; IT WOULD BE SOLD UNDER A DIFFERENT PART NUMBER SINCE IT IS ONLY INDICATED TO BE USED AS A HEMI IN THE US AT THIS TIME. 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
DEVELOPED PAIN, REDUCED ROM, AND AUDIBLE 'GRATING' OF THE JOINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR ACETABULAR IMPLANT 56 | TOTAL HIP REPLACEMENT | KWB | DEPUY INTERNATIONAL, LTD. | NA | 2401959 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |