FDA Adverse Event
Injury
Summary report: N
SROM FEM NMH X SML 66 X 58 W/PIN L
MDR report key: 446940
·
Received March 10, 2003
Report
- Report Number
- 1818910-2003-00154
- Event Type
- Injury
- Date Received
- March 10, 2003
- Date of Event
- September 12, 2002
- Report Date
- March 10, 2003
- Manufacturer
- DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
- Product Code
- JWH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A CLINICAL POST-MARKET RECORD REVIEW REVEALED THAT THIS PT SUFFERED A FRACTURE TO BOTH THE FEMUR AND TIBIA DURING THE LEFT SIDE TOTAL KNEE PROCEDURE. THE DOCTOR DID NOT BLAME THE DEVICES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SROM FEM NMH X SML 66 X 58 W/PIN L | TOTAL KNEE PROSTHESIS | JWH | DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |