BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA HEAD, 12/14, 32 X -3.5

    MDR report key: 2880962 · Received December 13, 2012

    Report

    Report Number
    9613350-2012-01157
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 21, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES FOR REVIEW. THE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE AVAILABLE EVENT DESCRIPTION POINTS TO CAUSE OUTSIDE OUR AREA OF RESPONSIBILITY. THERE IS NO INDICATION OF A PRODUCT FAILURE. WITH THE INFORMATION GIVEN SO FAR, NO FURTHER INVESTIGATION IS POSSIBLE. WE WILL SUBMIT AN UPDATED REPORT ONCE THE PRODUCT HAS BEEN RECEIVED AND INVESTIGATED. ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012, A (B)(6) FEMALE PATIENT RECEIVED A BIOLOX DELTA HEAD, 12/14, 32 X -3.5. ON AN UNKNOWN DATE, THE PATIENT "BENT OVER IN AN AWKWARD POSITION AND DISLOCATED HER HIP." PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012 TO FURTHER STABILIZE HER HIP JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOLOX DELTA HEAD, 12/14, 32 X -3.5 BIOLOX DELTA CERAMIC FEMORAL HEAD KWY ZIMMER GMBH 2652018

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R