FDA Adverse Event
Malfunction
Summary report: N
TRITANIUM ACETABULAR TRIAL 54MM
MDR report key: 2861205
·
Received November 2, 2012
Report
- Report Number
- 2249697-2012-02157
- Event Type
- Malfunction
- Date Received
- November 2, 2012
- Date of Event
- October 8, 2012
- Report Date
- October 8, 2012
- Manufacturer
- STRYKER ORTHOAPEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT IN THE ACETABULAR REAMER TRAY AND THE 54 WINDOW TRIAL STRIPPED OUT WHERE THE IMPACTOR HANDLE THREADS ON. AFTER 5 MINUTES OF PRODDING, THE TRIAL WAS REMOVED FROM THE PATIENT AND THE SURGEON COMPLETED THE CASE; HOWEVER, THE TRIAL CANNOT BE USED ANY LONGER AND HAS BEEN REMOVED FROM THE SET AND WILL BE RETURNED TO STRYKER FOR INVESTIGATION. THIS WAS USED DURING A PRIMARY LEFT HIP SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRITANIUM ACETABULAR TRIAL 54MM | INSTRUMENT | LXH | STRYKER ORTHOAPEDICS MAHWAH | NA | 4V3MAD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |