FDA Adverse Event
Injury
Summary report: N
TRIATHLON CR X3 TIBIAL INSERT
MDR report key: 2232480
·
Received August 25, 2011
Report
- Report Number
- 2249697-2011-01252
- Event Type
- Injury
- Date Received
- August 25, 2011
- Date of Event
- August 3, 2011
- Report Date
- August 3, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K051146
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
DR (B)(6). COMMENTED THAT THERE WAS HAEMOARTHROSIS ONCE HE HAD OPENED THE KNEE. HE SAID THE BASEPLATE AND FEMUR APPEARED WELL FIXED AND HE COMMENTED THAT THERE WAS SOME STRESS SHIELDING EVIDENT UNDER THE ANTERIOR PART OF THE BASEPLATE. HE TOOK OUT THE 9MM CR INSERT AND REPLACED IT WITH A 13MM CS LIPPED INSERT. HE SAID THAT PERHAPS THE PT HAD REQUIRED A THICKER POLY INSERT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON CR X3 TIBIAL INSERT | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | MET2KH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |