FDA Adverse Event
Injury
Summary report: N
TRIATHLON PRIM TIB BASEPLATE - CEMENTED
MDR report key: 2042243
·
Received March 29, 2011
Report
- Report Number
- 2249697-2011-00384
- Event Type
- Injury
- Date Received
- March 29, 2011
- Date of Event
- March 4, 2011
- Report Date
- March 4, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K040267
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR DUE TO HOSPITAL POLICY. ADD'L INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "REVISION DUE TO LOOSE TIBIA. INSERT WAS DAMAGED DURING EXPLANT, SO ITEM NUMBER AND LOT CODE WERE ILLEGIBLE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON PRIM TIB BASEPLATE - CEMENTED | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | UHBB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |