BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM

    MDR report key: 4101669 · Received September 19, 2014

    Report

    Report Number
    0002249697-2014-03560
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: MANUFACTURING DATE. AN EVENT REGARDING LOOSENING AND MIGRATION OF THE SHELL INVOLVING A PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS THE DEVICE WAS NOT RECEIVED FOR EVALUATION. A DEVICE HISTORY REVIEW INDICATED THAT THE SPECIFIED LOT WAS ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE NOT BEEN ANY OTHER EVENTS FOR THE SPECIFIED LOT. THE STEM WAS REPORTED TO BE WELL FIXED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION IS NEEDED TO DETERMINE THE ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A RIGHT HIP REVISION DUE TO THE CUP LOOSEN AND ROTATED INTO VERTICAL POSITION. THE STEM WAS WELL FIXATED . SALES REP IS ONLY ALLOWED TO PROVIDE IMPLANT SHEET. NO OTHER RECORDS AVAILABLE PER HOSPITAL POLICY.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A RIGHT HIP REVISION DUE TO THE CUP LOOSEN AND ROTATED INTO VERTICAL POSITION. THE STEM WAS WELL FIXATED . SALES REP IS ONLY ALLOWED TO PROVIDE IMPLANT SHEET. NO OTHER RECORDS AVAILABLE PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584650 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MLM1W2

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention