FDA Adverse Event
Injury
Summary report: N
ASR UNI FEMORAL IMPL SIZE 45
MDR report key: 2011290
·
Received March 4, 2011
Report
- Report Number
- 1818910-2011-03467
- Event Type
- Injury
- Date Received
- March 4, 2011
- Date of Event
- January 10, 2011
- Report Date
- February 3, 2011
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- KWA
- PMA / PMN Number
- K040627
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- 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
PT WAS REVISED TO ADDRESS HIP PAIN AND ACETABULAR LOOSENING. LITIGATION PAPERS RECEIVED. THE LAWSUIT ALLEGES THE PT HAD ELEVATED METAL ION LEVELS, EXCESS METALS IN HER BLOODSTREAM AND PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR UNI FEMORAL IMPL SIZE 45 | 87KWA | KWA | DEPUY INTERNATIONAL, LTD. | NA | 2747803 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |