BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON CR X3 TIBIAL INSERT

    MDR report key: 3071373 · Received April 22, 2013

    Report

    Report Number
    0002249697-2013-01362
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    MATERIAL ANALYSIS WAS PERFORMED ON THE RETURNED INSERT AND CONCLUDED THAT NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED. INSUFFICIENT MEDICAL RECORDS WERE RECEIVED FOR MEDICAL REVIEW. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT DATABASES SHOW THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT ID. ROOT CAUSE COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION AVAILABLE AT THE TIME OF THE EVALUATION. IF X-RAYS, MEDICAL RECORDS, AND OPERATIVE REPORTS WERE MADE AVAILABLE, THEY COULD HELP IN DETERMINING THE ROOT CAUSE OF THE REPORTED EVENT. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THE SURGEON OF THE HOSPITAL THAT SHE WAS PERFORMING A SURGERY PROCEDURE. THIS PROCEDURE TOOK PLACE TO CHANGE THE INLAY BECAUSE OF A RUPTURE OF THE QUADIPZES FIBER. FURTHER SHE OBSERVED THAT THE REMOVED INLAY SHOWS DISCOLORATIONS AND WEAR MARKS. SHE STATED THAT THE INLAY HAS BEEN IMPLANTED 5 MONTHS AGO.

    Description of Event or Problem · 1

    IT IS REPORTED THE SURGEON OF THE HOSPITAL THAT SHE WAS PERFORMING A SURGERY PROCEDURE. THIS PROCEDURE TOOK PLACE TO CHANGE THE INLAY BECAUSE OF A RUPTURE OF THE "QUADIPZES" FIBER. FURTHER SHE OBSERVED THAT THE REMOVED INLAY SHOWS DISCOLORATIONS AND WEAR MARKS. SHE STATED THAT THE INLAY HAS BEEN IMPLANTED 5 MONTHS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173001 TRIATHLON CR X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention