BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRITANIUM REVISION ACETABULAR

    MDR report key: 3926450 · Received July 10, 2014

    Report

    Report Number
    0002249697-2014-02618
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K010170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING METALLOSIS INVOLVING A TRITANIUM REVISION ACETABULAR WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO ITEMS WERE RETURNED. REVIEW OF THE PROVIDED PATIENT DETAILS AND REPORTED EVENT BY A CLINICAL CONSULTANT CONCLUDED THAT THE PROBABILITY OF DEVICE-RELATED MECHANISMS APPEARS VERY LOW TO ABSENT WHILE PATIENT OBESITY MAY HAVE PLAYED A SECONDARY BUT CERTAINLY NOT A PRINCIPAL ROLE IN THE FAILURE SCENARIO. 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 RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION OF RIGHT ACETABULAR. DOCTOR STATED THERE WAS SIGNIFICANT METALLOSIS BETWEEN MDM LINER AND TRITANIUM SHELL. ALSO SIGNIFICANT METALLOSIS BETWEEN SHELL AND BONE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION OF RIGHT ACETABULAR. DOCTOR STATED THERE WAS SIGNIFICANT METALLOSIS BETWEEN MDM LINER AND TRITANIUM SHELL. ALSO SIGNIFICANT METALLOSIS BETWEEN SHELL AND BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404117 TRITANIUM REVISION ACETABULAR IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MKL31R

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention