BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DOUBLE MOBILITY LINER

    MDR report key: 2613816 · Received December 23, 2009

    Report

    Report Number
    3005180920-2009-00008
    Event Type
    Injury
    Date Received
    December 23, 2009
    Date of Event
    October 4, 2009
    Report Date
    November 24, 2009
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JDI
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFG RECORDS AND QUALITY DOCUMENTS WERE REVIEWED. THE MFG AND QUALITY DOCUMENT REVIEW CONFIRMED THAT ALL POLYETHYLENE LINERS RELEASED TO THE FIELD OF LOT NUMBER 090085 (B)(4) CONFORM TO THE SPECIFICATION VALID AT THE TIME OF MFR, INCLUDING DIMENSIONAL AND SHAPE VALUES. THE STERILIZATION CYCLE FOR LOT NUMBER 090085 WAS PERFORMED ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. LEG LENGTH INEQUALITY AND INFECTION ARE KNOWN COMPLICATIONS FOR HIP SURGERY.

    Description of Event or Problem · 1

    INITIALLY, THE SUBJECT PRESENTED WITH A LEG LENGTH INEQUALITY AND HE WAS NOT SATISFIED WITH THE SURGERY. THE SUBJECT UNDERWENT A REVISION SURGERY TO REPLACE THE LINER SO THAT LEG LENGTHS WOULD BE MORE EQUAL. THE REVISION SURGERY WENT AS PLANNED EXCEPT THE WOULD BECAME INFECTED WITH DIPHTHEROIDS. THE SUBJECT IS CURRENTLY FINISHING A POST OPERATIVE COURSE OF IV ANTIBIOTICS AND THE FINAL OUTCOME CANNOT BE ASSESSED AT THIS TIME. THE SURGEON CLASSIFIED THE INFECTION AS PROBABLY NOT DEVICE RELATED. THERE IS NO ADDITIONAL REVISION SURGERY EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAFITCUP DOUBLE MOBILITY LINER POLYETHYLENE LINER JDI MEDACTA INTERNATIONAL, SA NA 090085

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention LOT 090243| COTYLE VERS., CUP METAL BACK 52MM: 01.26.52MB,| LOT 082796| QUADRA STEM STD, 12/14 S.5: 01.12.025, LOT 090496| BIOLOX FEMORAL HEAD 28MM: 38.39.7175.245.00,