FDA Adverse Event
Malfunction
Summary report: N
TRIDENT ACET WINDOW TRIAL 50MM
MDR report key: 2945758
·
Received January 4, 2013
Report
- Report Number
- 2249697-2013-90041
- Event Type
- Malfunction
- Date Received
- January 4, 2013
- Date of Event
- December 10, 2012
- Report Date
- December 12, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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 WHEN THE SURGEON WAS REMOVING THE TRIDENT ACET WINDOW TRIAL 50MM FROM THE PT ACETABULUM BY USING THE UNIVERSAL IMPACTOR/POSITIONER, HE NOTICED SOME METAL FRAGMENTS AROUND THE TRIAL. HE REMOVED ALL FRAGMENTS FROM THERE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5613 | TRIDENT ACET WINDOW TRIAL 50MM | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | MJA75H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |