X3 TRIATHLON CS INSERT #5 9MM
Report
- Report Number
- 0002249697-2022-00022
- Event Type
- Injury
- Date Received
- January 5, 2022
- Date of Event
- December 1, 2021
- Report Date
- March 4, 2022
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- MBH
- UDI-DI
- 07613327045871
- PMA / PMN Number
- K141056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.
REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.
UPON FURTHER INVESTIGATION MFR REPORT #: 0002249697-2021-02075 AND MFR REPORT #: 0002249697-2022-00022 ARE THE SAME EVENT FOR THE SAME PATIENT. SINCE THE SAME FAILURE FOR THE SAME DEVICE HAS BEEN REPORTED TWICE, MFR REPORT 0002249697-2022-00022 IS BEING CANCELLED, AND ANY FURTHER CORRESPONDENCE WILL BE SUBMITTED UNDER MFR REPORT 0002249697-2021-02075.
THE FOLLOWING WAS REPORTED: "PATIENT TREATED FOR PTG REVISION BECAUSE OF UNSTABLE PROSTHESIS, THE POLYETHYLENE IN PLACE WAS BROKEN. SURGICAL REVISION."
THE FOLLOWING WAS REPORTED: "PATIENT TREATED FOR PTG REVISION BECAUSE OF UNSTABLE PROSTHESIS, THE POLYETHYLENE IN PLACE WAS BROKEN. SURGICAL REVISION."
THE FOLLOWING WAS REPORTED: "PATIENT TREATED FOR PTG REVISION BECAUSE OF UNSTABLE PROSTHESIS, THE POLYETHYLENE IN PLACE WAS BROKEN. SURGICAL REVISION".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1436798 | X3 TRIATHLON CS INSERT #5 9MM | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO | MBH | STRYKER ORTHOPAEDICS-MAHWAH | 5531-G-509 | LHU151 | 07613327045871 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention| R| H| H |