BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V40 COCR LFIT HEAD 40MM/+0

    MDR report key: 4100035 · Received September 18, 2014

    Report

    Report Number
    0002249697-2014-03545
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    September 7, 2011
    Report Date
    September 2, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K061434
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) INCHES IN HEIGHT. AN EVENT REGARDING TAPER CORROSION INVOLVING A METAL FEMORAL HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: CLINICIAN REVIEW OF THE PROVIDED RECORDS CONCLUDED: "THERE IS NO CONFIRMATION THAT THE AMOUNT OF CORROSION DESCRIBED WITHIN THE FEMORAL HEAD/TRUNNION ARTICULATION WAS MORE THAN NORMALLY EXPECTED AFTER SEVERAL YEARS IN SITU AND WAS RESPONSIBLE FOR THE SYMPTOMS DESCRIBED IN BOTH HIPS." DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW FOUND NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THE SUBJECT MANUFACTURING LOT. CONCLUSIONS: THE REPORTED CORROSION COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR INSPECTION.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN STRYKER RIGHT HIP. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD RIGHT HIP REVISION DUE TO PAIN AND METALLOSIS RESULTING IN LOSS OF MUSCULATURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD RIGHT HIP REVISION DUE TO PAIN AND METALOSIS RESULTING IN LOSS OF MUSCULATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578327 V40 COCR LFIT HEAD 40MM/+0 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH MKE0D1

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention