FDA Adverse Event
Injury
Summary report: N
PFC SIGMARP STB TB IN 2 12.5
MDR report key: 1153224
·
Received September 4, 2008
Report
- Report Number
- 1818910-2008-03610
- Event Type
- Injury
- Date Received
- September 4, 2008
- Date of Event
- August 5, 2008
- Report Date
- August 5, 2008
- Manufacturer
- DEPUY - CORK, A DIVISION OF DEPUY ORTHOPAEDICS
- Product Code
- NJL
- PMA / PMN Number
- P830055/S074
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- 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
DURING SURGERY, THE MBT TRAY IMPACTOR HANDLE WOULD NOT DISASSOCIATED FROM THE TRAY AFTER IMPACTION. THE TRAY HAD TO BE REMOVED AND WAS DISLODGED VIA MALLET. IT WAS ALSO NOTED THAT THE INSERT TO BE IMPLANTED WAS EXPIRED. THE SURGERY TIME WAS EXTENDED APPROX. 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PFC SIGMARP STB TB IN 2 12.5 | 87NJL | NJL | DEPUY - CORK, A DIVISION OF DEPUY ORTHOPAEDICS | NA | 1079565 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |