BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 58MM

    MDR report key: 3253245 · Received July 29, 2013

    Report

    Report Number
    0002249697-2013-02484
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 5, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS SENT TO PATHOLOGY AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING SHELL LOOSENING AFTER A FALL INVOLVING A TRITANIUM HEMI CLUSTER HOLE SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. -MEDICAL RECORDS RECEIVED AND EVALUATION: THE PROVIDED MEDICAL INFORMATION WAS SUBMITTED TO A CONSULTING CLINICIAN WHO DEEMED IT INSUFFICIENT FOR A MEDICAL REVIEW. -DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. ADDITIONAL MEDICAL RECORDS AND OPERATIVE REPORTS ARE NEEDED. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Description of Event or Problem · 1

    PATIENT FELL AND CREATED A LOOSE CUP. WE REMOVED CUP AND INSERTED ANOTHER CUP WITH SCREWS. I DO NOT HAVE AN EXACT DATE FOR THE SURGERY PRIOR TO TODAY'S REVISION.

    Description of Event or Problem · 1

    PATIENT FELL AND CREATED A LOSE CUP. WE REMOVED CUP AND INSERTED ANOTHER CUP WITH SCREWS. I DO NOT HAVE AN EXACT DATE FOR THE SURGERY PRIOR TO TODAY'S REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353411 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 58MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MMA6HT

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention