BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 3023907 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01123
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LAXITY AND INSTABILITY INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION INDICATED THE REPORTED INSERT WAS RETURNED WITH THE LOCKING DISASSOCIATED FROM THE INSERT BODY. THE DEVICE SHOWS SIGNS CONSISTENT IN-VIVO SERVICE. NO OTHER OBSERVATIONS COULD BE MADE OF THE DEVICE. -MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -DEVICE HISTORY REVIEW: THERE HAVE BEEN NO REPORTED DISCREPANCIES FOR THE REFERENCED LOT. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN OTHER EVENTS FOR THE REFERENCED LOT. CONCLUSIONS: THE REPORTED REVISION COULD BE CONFIRMED AS THE EXPLANTED DEVICE WAS RETURNED; HOWEVER, THE REPORTED FAILURE MODE OF INSTABILITY COULD NOT BE CONFIRMED. EVALUATION OF THE RETURNED DEVICE DID NOT PROVIDE MEANINGFUL INSIGHT INTO THE CAUSE OF THE REPORTED EVENT. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS PRE AND POSTOPERATIVE REPORTS, PROGRESS NOTES AND DATED PRE- AND POST-OPERATIVE X-RAYS ARE NEEDED FOR DETERMINING ROOT CAUSE. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INSTABILITY MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR LAXITY AND PAIN. REMOVED A 9MM INSERT AND REPLACED IT WITH A 13MM #5532-G-313, LOT: MLT1K9.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR LAXITY AND PAIN. REMOVED A 9MM INSERT AND REPLACED IT WITH A 13MM #5532-G-313 LOT: MLT1K9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127334 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MKE4AK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention