BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEADS 32 SIZE M.

    MDR report key: 2194710 · Received July 29, 2011

    Report

    Report Number
    3005180920-2011-00042
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 29, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT UNDERWENT A PRIMARY THR ON THE (B)(6), 2011. A QUADRA H STEM SIZE 9 WAS IMPLANTED (K082792) BUT SIZE 10 MAY HAVE BEEN A BETTER FIT DUE TO SIZE OF CANAL. THE STEM SUBSIDED AND THE SURGEON HAS DECIDED TO PERFORM A REVISION SURGERY, HAPPENED ON THE (B)(6) 2011. DURING THE REVISION, THE STEM WAS NOT REMOVED, BUT ONLY THE COCR BALL HEAD WAS SUBSTITUTED. THE BALL HEAD INITIALLY IMPLANTED WAS A 32 MM DIAMETER SIZE M (OFFSET 0). THE SURGEON REPLACED IT WITH A CERAMIC BALL HEAD 32 MM DIAMETER SIZE XL (OFFSET +7). HE DECIDE TO NOT REPLACE THE STEM BECAUSE IT WAS STABLE. THE REVISION SURGERY WAS DUE TO A WRONG DECISION MADE BY THE SURGEON DURING THE PRIMARY SURGERY, WHEN HE DECIDED THE SIZES OF THE IMPLANTS.

    Description of Event or Problem · 1

    QUADRA H STEM SUBSIDED AND THE SURGEON HAS DECIDED TO PERFORM A REVISION SURGERY, HAPPENED ON THE (B)(6) 2011. DURING THE REVISION, THE STEM WAS NOT REMOVED, BUT ONLY THE COCR BALL HEAD WAS SUBSTITUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COCR BALL HEADS 32 SIZE M. FEMORAL BALL HEAD JDI MEDACTA INTERNATIONAL SA 083557

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention QUADRA H CEMENTLESS STEM SIZE 9| (B)(4) / LOT 080652