FDA Adverse Event
Malfunction
Summary report: N
EXETER V40 STEM 50MM NO 4
MDR report key: 1853944
·
Received September 29, 2010
Report
- Report Number
- 9616680-2010-00605
- Event Type
- Malfunction
- Date Received
- September 29, 2010
- Date of Event
- September 14, 2010
- Report Date
- September 14, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS CAEN
- Product Code
- JDI
- PMA / PMN Number
- K011623
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INNER PLASTIC TRAY CONTAINING THE IMPLANT WAS CRACKED/BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXETER V40 STEM 50MM NO 4 | IMPLANT | JDI | STRYKER ORTHOPAEDICS CAEN | NA | G1315535 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |