FDA Adverse Event
Injury
Summary report: N
TRIATHLON PRIM TIB BASEPLATE - CEMENTED
MDR report key: 1030735
·
Received April 17, 2008
Report
- Report Number
- 2249697-2008-00095
- Event Type
- Injury
- Date Received
- April 17, 2008
- Date of Event
- March 21, 2008
- Report Date
- March 21, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- HSH
- PMA / PMN Number
- K031729
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PT COMPLAINED OF PAIN ALMOST IMMEDIATELY POST OP. X-RAYS WERE TAKEN AND REVISION WAS SCHEDULED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON PRIM TIB BASEPLATE - CEMENTED | IMPLANT | HSH | STRYKER ORTHOPAEDICS MAHWAH | NA | VIZS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |