BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL IMPACTOR/POSTIONER

    MDR report key: 5145580 · Received October 13, 2015

    Report

    Report Number
    0002249697-2015-03340
    Event Type
    Injury
    Date Received
    October 13, 2015
    Date of Event
    September 15, 2015
    Report Date
    May 25, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MAY
    PMA / PMN Number
    K123604
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING FRACTURED HANDLE INVOLVING A UNIVERSAL IMPACTOR/POSITIONER WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: THE RETURNED DEVICE WAS IN USED CONDITION. THE VISUAL INSPECTION CONFIRMED THE FRACTURED HANDLE. -MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS WERE RECEIVED. -DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAS BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. CONCLUSIONS: THE INVESTIGATION CONCLUDED THE HANDLE WAS CRACKED DUE TO A DESIGN ISSUE. A CAPA AND ECN WERE ISSUED. AN ECN WAS INITIATED ON APR-2008 FOR THE MODIFICATION OF THE RADEL HANDLE, INTERNAL SHAFT GEOMETRY, AND STRIKE PLATE OF THE UNIVERSAL IMPACTOR/POSTIONER, CATALOG: 2101-0200. THE CAPA WAS CLOSED AND THE ECN IMPLEMENTED ON 27-OCT-2010.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A SECOND SUPPLEMENTAL REPORT IS BEING SUBMITTED ON 5/1/2017 TO CORRECT THE LOT CODE AND ADD THE CORRESPONDING MANUFACTURING DATE.

    Description of Event or Problem · 1

    CUP IMPACTOR BROKE AT SHAFT/HANDLE. WHITE PLASTIC HANDLE SPLIT IN THREE PLACES. AT THE SAME TIMETRITANIUM SHELL PENETRATED THROUGH MEDIAL WALL OF ACETABULUM.

    Description of Event or Problem · 1

    CUP IMPACTOR BROKE AT SHAFT/HANDLE. WHITE PLASTIC HANDLE SPLIT IN THREE PLACES. AT THE SAME TIMETRITANIUM SHELL PENETRATED THROUGH MEDIAL WALL OF ACETABULUM.

    Description of Event or Problem · 1

    CUP IMPACTOR BROKE AT SHAFT/HANDLE. WHITE PLASTIC HANDLE SPLIT IN THREE PLACES. AT THE SAME TIME TRITANIUM SHELL PENETRATED THROUGH MEDIAL WALL OF ACETABULUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677232 UNIVERSAL IMPACTOR/POSTIONER PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS MAY STRYKER ORTHOPAEDICS-MAHWAH BWWAC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other