BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON INSERT CR#7 11MM

    MDR report key: 2913900 · Received January 14, 2013

    Report

    Report Number
    0002249697-2013-00037
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR INDICATES DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO DISCREPANCIES. THE CHR INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR LOT. VISUAL EVALUATION CONFIRMED THE EVENT. MAR CONCLUDED "THIRD BODY INDENTATIONS, SCRATCHING THE ARTICULATING SURFACE OF INSERT ARE COMMONLY IDENTIFIED ON UHMWPE INSERTS, LIKELY WERE CAUSED BY THE LOOSE BONE CEMENT FROM BROKEN PATELLA." NO MATERIAL OR MANUFACTURING DEFECTS OBSERVED." PRE/POST-OPERATIVE X-RAYS AND THE PRIMARY OP REPORT, PATIENT HISTORY, FOLLOW-UP NOTES NOT PROVIDED TO COMPLETE A FULL INVESTIGATION, THE INVESTIGATION RESULTS SUGGEST THAT PATIENT FACTORS CONTRIBUTED TO EVENT. IN ADDITION, THIRD BODY WEAR IS A KNOWN ISSUE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATELLA PEGS SEPARATED FROM PATELLA DOME. VIRTUALLY NO CEMENT WAS FOUND ON THE BACK OF THE PATELLA EXCEPT FOR CEMENT IN THE PEG HOLES. UPON EXAMINATION OF THE CR BEARING INSERT, THE SURGEON NOTICED A PITTED SURFACE AND CONCLUDED THAT THE WEAR CAME FROM THIRD BODY WEAR (CEMENT FROM THE PATELLA). SURGEON REPLACED THE PATELLA WITH A (B)(4) AND REPLACED THE BEARING INSERT WITH A (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATELLA PEGS SEPARATED FROM PATELLA DOME. VIRTUALLY NO CEMENT WAS FOUND ON THE BACK OF THE PATELLA EXCEPT FOR CEMENT IN THE PEG HOLES. UPON EXAMINATION OF THE CR BEARING INSERT, THE SURGEON NOTICED A PITTED SURFACE AND CONCLUDED THAT THE WEAR CAME FROM THIRD BODY WEAR (CEMENT FROM THE PATELLA). SURGEON REPLACED THE PATELLA WITH A 5550-6-339 AND REPLACED THE BEARING INSERT WITH A 5531-6-716.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19890 X3 TRIATHLON INSERT CR#7 11MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH L135072

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention