FDA Adverse Event
Injury
Summary report: N
PFC SIGMA MOD TIB TRAY CEM SZ5
MDR report key: 1153052
·
Received September 5, 2008
Report
- Report Number
- 1818910-2008-03878
- Event Type
- Injury
- Date Received
- September 5, 2008
- Date of Event
- July 30, 2008
- Report Date
- August 6, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- JWH
- PMA / PMN Number
- K884796
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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
FURTHER INFORMATION RECEIVED 14 AUGUST - COMPONENT FAILURE. THE INSERT WAS WORN MEDIALLY, AND THERE WAS A FRACTURE OF THE TIBIAL TRAY ORIGINATING POSTERIORLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PFC SIGMA MOD TIB TRAY CEM SZ5 | 87 JWH | JWH | DEPUY ORTHOPAEDICS, INC. | NA | 181594 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |