BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM

    MDR report key: 4093900 · Received September 16, 2014

    Report

    Report Number
    0002249697-2014-03508
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CUP LOOSENING INVOLVING A PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO ITEMS WERE RECEIVED. MEDICAL EVALUATION NOT PERFORMED AS NO MEDICAL RECORDS WERE RECEIVED. DEVICE HISTORY REVIEW INDICATED ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NO MEDICAL RECORDS AND/OR DEVICE WERE PROVIDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    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 WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    STEM STAYED. HEAD REPLACED. CUP AND POLY REMOVED DUE TO LOOSENING AND REPLACED WITH COMPETITIVE COMPANY RIGHT HIP.

    Description of Event or Problem · 1

    STEM STAYED. HEAD REPLACED. CUP AND POLY REMOVED DUE TO LOOSENING AND REPLACED WITH COMPETITIVE COMPANY RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571306 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MJRK70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention