FDA Adverse Event
Injury
Summary report: N
ASR UNI FEMORAL IMPLANT SZ 45
MDR report key: 1960916
·
Received January 11, 2011
Report
- Report Number
- 1818910-2010-10718
- Event Type
- Injury
- Date Received
- January 11, 2011
- Date of Event
- December 3, 2010
- Report Date
- February 6, 2026
- 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
- Health Professional
- N
Narratives
Description of Event or Problem · 1
THE PATIENT WAS REVISED TO ADDRESS PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR UNI FEMORAL IMPLANT SZ 45 | 87KWA | KWA | DEPUY INTERNATIONAL, LTD. | NA | 2361457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |