BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA V-40 CERAMIC HEAD 32/-4

    MDR report key: 5514731 · Received March 21, 2016

    Report

    Report Number
    0002249697-2016-00970
    Event Type
    Malfunction
    Date Received
    March 21, 2016
    Date of Event
    March 7, 2016
    Report Date
    March 7, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K052718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A SIZE/FIT ISSUE INVOLVING A CERAMIC HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. VISUAL INSPECTION: EXTENSIVE SCRATCHES WERE OBSERVED ON INTERNAL SURFACE AND RIM OF THE RETURNED CERAMIC HEAD. DIMENSIONAL INSPECTION: THE DEVICE WAS FOUND TO BE DIMENSIONALLY WITHIN SPECIFICATION AS PER IGS-0031993 (REF. ATTACHED INSPECTION), IT WAS NOTED THAT FOR SEQ # 9 (LASERMARK INFO) AND SEQ 10 (WORKMANSHIP) THAT THE CERAMIC HEAD WAS MARKED. FUNCTIONAL INSPECTION: A FUNCTIONAL INSPECTION WAS NOT PERFORMED AS THE EVENT CANNOT BE REPLICATED. DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: A DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE, ALL FEATURES CONFORMED TO THE REQUIRED SPECIFICATIONS. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF FURTHER RELEVANT INFORMATION BECOMES AVAILABLE THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    SURGEON STATED HE DID NOT FEEL THAT BIOLOX V40 HEAD WAS FITTING CORRECTLY ON TO IMPLANTED STEM. ANOTHER FEMORAL HEAD WAS OPENED AND IMPLANTED WITHOUT FURTHER INCIDENCE. THIS WAS FOR THE LEFT HIP.

    Description of Event or Problem · 1

    SURGEON STATED HE DID NOT FEEL THAT BIOLOX V40 HEAD WAS FITTING CORRECTLY ON TO IMPLANTED STEM. ANOTHER FEMORAL HEAD WAS OPENED AND IMPLANTED WITHOUT FURTHER INCIDENCE. THIS WAS FOR THE LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171038 DELTA V-40 CERAMIC HEAD 32/-4 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO STRYKER ORTHOPAEDICS-MAHWAH 51267201

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other