BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM STD V40 TAPER VIT HEAD

    MDR report key: 6455381 · Received April 3, 2017

    Report

    Report Number
    0002249697-2017-01105
    Event Type
    Injury
    Date Received
    April 3, 2017
    Date of Event
    March 7, 2017
    Report Date
    June 1, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    07613327012873
    PMA / PMN Number
    K121308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 SIZ/FIT ISSUE INVOLVING A METAL HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION OF THE RETURN PART WAS CARRIED OUT. BIOLOGICAL MATERIAL WAS NOTED ON THE TAPER HEAD FROM ATTEMPTED IMPLANTATION. OTHERWISE THE DEVICE WAS VISUALLY UNREMARKABLE DIMENSIONAL INSPECTION WAS CARRIED OUT ON THE RETURNED HEAD USING IGS-0030144 VERSION 7. ALL DIMENSIONS WERE FOUND TO BE WITHIN SPECIFICATION. MEDICAL RECORDS RECEIVED AND EVALUATION: NO INFORMATION WAS RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. NO ADVERSE IMPACT TO PATIENT WAS NOTED. DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED, THE METAL HEAD WAS FOUND TO BE DIMENSIONALLY WITHIN SPECIFICATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON, WAS ATTEMPTING TO IMPACT A V40 COCR SIZE 32MM +0 FEMORAL HEAD ONTO A SIZE 7-132° ACCOLADE 2 STEM. UPON IMPACT IT DID NOT WELD ONTO THE STEM TRUNION. HE CLEANED THE FEMORAL HEAD AND ATTEMPTED TO IMPACT AGAIN WITH THE SAME RESULT. WE BROUGHT IN ANOTHER FEMORAL HEAD OF THE SAME SIZE AND IT WORKED FINE UPON IMPACT. IT WAS REPORTED THAT A SURGICAL DELAY OF LESS THAN 10 MINUTES WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON, WAS ATTEMPTING TO IMPACT A V40 COCR SIZE 32MM +0 FEMORAL HEAD ONTO A SIZE 7-132° ACCOLADE 2 STEM. UPON IMPACT, IT DID NOT WELD ONTO THE STEM TRUNION. HE CLEANED THE FEMORAL HEAD AND ATTEMPTED TO IMPACT AGAIN WITH THE SAME RESULT. WE BROUGHT IN ANOTHER FEMORAL HEAD OF THE SAME SIZE AND IT WORKED FINE UPON IMPACT. IT WAS REPORTED THAT A SURGICAL DELAY OF LESS THAN 10 MINUTES WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237639 32MM STD V40 TAPER VIT HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 57552403 07613327012873

    Patients

    Seq Age Sex Outcome Treatment
    1 Other