FDA Adverse Event
Injury
Summary report: N
DEPUY ASR SIZE 49 FEMORAL IMPLANT
MDR report key: 964041
·
Received December 12, 2007
Report
- Report Number
- 1818910-2007-04004
- Event Type
- Injury
- Date Received
- December 12, 2007
- Date of Event
- October 16, 2007
- Report Date
- November 14, 2007
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- KXA
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO K# SUBMITTED AS DEPUY ORTHOPAEDIC SELLS A SIMILAR PRODUCT (OR THE SAME PRODUCT WITH A DIFFERENT PRODUCT CODE) IN THE US. 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
PRODUCT WAS REVISED BECAUSE OF NECK FRACTURE AFTER SIX MONTHS POST-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEPUY ASR SIZE 49 FEMORAL IMPLANT | 87KXA | KXA | DEPUY INTERNATIONAL, LTD. | NA | 2319268 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA YR | Required Intervention |