FDA Adverse Event
Malfunction
Summary report: N
TRIDENT 10 CROSSFIRE INSERT 28 MM ID
MDR report key: 1250786
·
Received December 1, 2008
Report
- Report Number
- 9616680-2008-00400
- Event Type
- Malfunction
- Date Received
- December 1, 2008
- Date of Event
- October 30, 2008
- Report Date
- October 30, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K983502
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE THA SURGERY, THE SURGEON IMPLANTED THE TRIAD CUP. IT WAS FURTHER REPORTED THAT THE SURGEON COULD NOT LOCK THE TRIDENT CROSSFIRE INSERT WITH THE TRIAD CUP. HE IMPLANTED ANOTHER TRIDENT CROSSFIRE INSERT WITHOUT PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT 10 CROSSFIRE INSERT 28 MM ID | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 27781101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other |