BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRITANIUM REVISION ACETABULAR

    MDR report key: 3970124 · Received July 31, 2014

    Report

    Report Number
    0002249697-2014-02933
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K010170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. FURTHER INFORMATION HAS NOT BEEN MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING SHELL LOOSENING INVOLVING A TRITANIUM REVISION ACETABULAR WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL EVALUATION NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED FOR REVIEW. A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW. A COMPLAINT HISTORY REVIEW CONFIRMED NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE OF A LACK OF INFORMATION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT POOR BONE QUALITY, CUP LOOSENED AND DISLODGED. ALL COMPONENTS WERE REMOVED. RESTORATION WEDGE AUGMENT IMPLANTED TO RESTORE DEFECT. PATIENT WAS STABLE AFTER SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT POOR BONE QUALITY, CUP LOOSENED AND DISLODGED. ALL COMPONENTS WERE REMOVED. RESTORATION WEDGE AUGMENT IMPLANTED TO RESTORE DEFECT. PATIENT WAS STABLE AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446921 TRITANIUM REVISION ACETABULAR IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MNDXHP

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention