FDA Adverse Event
Malfunction
Summary report: N
TRIATHLON P/A CR BEADED #6L
MDR report key: 1963376
·
Received January 10, 2011
Report
- Report Number
- 9610726-2011-00006
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- December 27, 2010
- Report Date
- December 29, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- MBH
- PMA / PMN Number
- K051380
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "IMPLANTED AND DIDN'T LIKE THE WAY IT SAY, WAS SITTING HIGH. SURGEON THOUGHT IT MIGHT BE PATIENT ANATOMY, BUT NOT SURE, DIDN'T WANT TO TAKE A CHANCE AND SO USED A CEMENTED IMPLANT INSTEAD."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON P/A CR BEADED #6L | IMPLANT | MBH | STRYKER ORTHOPAEDICS LIMERICK | NA | SXS9A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Other |