FDA Adverse Event
Injury
Summary report: N
TRIATHLON-PS TIBIAL INSERT #3 - 19MM
MDR report key: 1160471
·
Received September 12, 2008
Report
- Report Number
- 9610726-2008-00062
- Event Type
- Injury
- Date Received
- September 12, 2008
- Date of Event
- August 26, 2008
- Report Date
- September 3, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- HSH
- PMA / PMN Number
- K031729
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT, "IMPLANT WAS REMOVED. IT WAS FREE FLOATING IN KNEE PT IS APPROX 4 MONTHS OUT FROM ORIGINAL SURGERY. REPLACED WITH #3 X 25MM INSERT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON-PS TIBIAL INSERT #3 - 19MM | IMPLANT | HSH | STRYKER ORTHOPAEDICS LIMERICK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |