BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPHERICAL CUP WINDOW TRIAL 58MM

    MDR report key: 3163146 · Received June 11, 2013

    Report

    Report Number
    0002249697-2013-01879
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING STRIPPED THREADS INVOLVING AN OMNIFIT ACETABULAR TRIAL WAS REPORTED. THE EVENT WAS CONFIRMED. VISUAL INSPECTION CONFIRMED THE REPORTED EVENT; THE WINDOW TRIAL THREADS WERE STRIPPED. NO EVIDENCE OF THE ORIGINAL THREAD CONDITION OR POTENTIAL CROSS-THREADING COULD BE DETERMINED DUE TO THE EXCESSIVE DAMAGE TO THE THREADS. A REVIEW OF MEDICAL RECORDS WAS NOT PERFORMED AS NONE WERE PROVIDED. NO FURTHER INFORMATION WAS REQUESTED AS IT IS NOT BELIEVED THE FAILURE WAS RELATED TO PATIENT FACTORS. A DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. A COMPLAINT HISTORY REVIEW FOUND THERE HAVE BEEN NO OTHER EVENTS FOR THE MANUFACTURING LOT. THE REPORTED THREAD DAMAGE WAS CONFIRMED. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED AS THE SEVERE DAMAGE TO THE THREADS MEANT NO EVIDENCE OF THE ORIGINAL THREAD CONDITION OR POTENTIAL CROSS-THREADING COULD BE OBSERVED. THE DAMAGE TO THE DEVICE IS CONSISTENT WITH PROLONGED USE, THIS DEVICE HAS REACHED THE END OF IT USEABLE SERVICE LIFE. THERE IS NO INDICATION THIS EVENT WAS RELATED TO MANUFACTURING FACTORS.

    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 WHILE DOING A LEFT TOTAL HIP (PRIMARY SURGERY) THE TIP ON THE UNIVERSAL SCREW DRIVER BROKE OFF DURING SURGERY - PIECE WAS FOUND AND REMOVED FROM THE PATIENT. ALSO, WHILE TRIALING FOR THE CUP, THE TRIAL STRIPPED OUT AND WOULD NOT SCREW ONTO THE IMPACTOR. THE SURGERY WAS COMPLETED WITHOUT ANY ISSUE/DELAY. NO FURTHER INFO WILL BE MADE AVAILABLE FROM THE HOSPITAL/SURGEON AND THE SURGEON DOES NOT WANT TO BE CONTACTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DOING A LEFT TOTAL HIP (PRIMARY SURGERY) THE TIP ON THE UNIVERSAL SCREW DRIVER BROKE OFF DURING SURGERY - PIECE WAS FOUND AND REMOVED FROM THE PATIENT. ALSO, WHILE TRIALING FOR THE CUP, THE TRIAL STRIPPED OUT AND WOULD NOT SCREW ONTO THE IMPACTOR. THE SURGERY WAS COMPLETED WITHOUT ANY ISSUE/DELAY. NO FURTHER INFO WILL BE MADE AVAILABLE FROM THE HOSPITAL/SURGEON AND THE SURGEON DOES NOT WANT TO BE CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263416 SPHERICAL CUP WINDOW TRIAL 58MM INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH MPE01

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other