FDA Adverse Event
Injury
Summary report: N
78/74 A/P RT FEMORAL
MDR report key: 237563
·
Received August 30, 1999
Report
- Report Number
- 1818910-1999-00129
- Event Type
- Injury
- Date Received
- August 30, 1999
- Date of Event
- July 28, 1999
- Report Date
- August 30, 1999
- Manufacturer
- DEPUY RAYNHAM, DIV. OF DEPUY ORTHOPAEDICS, INC.
- Product Code
- JWH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT WAS REVISED DUE TO A BROKEN FEMORAL COMPONENT (RT. SIDE). THE IMPLANT WAS BROKEN AT THE MEDIAL DISTAL/POSTERIOR ANGLE JUNCTION. THERE WERE NO UNUSUAL CIRCUMSTANCES AND THE PT IS A VERY ACTIVE; 62 YEAR OLD BANKER IN GOOD CONDITION; AT 6'4" HGT. 240 WT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 78/74 A/P RT FEMORAL Implant | TOTAL KNEE PROSTHESIS | JWH | DEPUY RAYNHAM, DIV. OF DEPUY ORTHOPAEDICS, INC. | NA | 067DI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |