FDA Adverse Event
Injury
Summary report: N
DEPUY ASR XL FEM IMP SIZE 45
MDR report key: 1063270
·
Received June 18, 2008
Report
- Report Number
- 1818910-2008-02468
- Event Type
- Injury
- Date Received
- June 18, 2008
- Date of Event
- May 13, 2008
- Report Date
- May 18, 2008
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- JDI
- 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
REVISION RIGHT HIP FOR HYPERSENSITIVITY REACTION TO METAL ON METAL BEARING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEPUY ASR XL FEM IMP SIZE 45 | TOTAL HIP REPLACEMENT | JDI | DEPUY INTERNATIONAL, LTD. | NA | 2225265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |