BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DOUBLE MOBILITY CUP

    MDR report key: 2824126 · Received October 15, 2012

    Report

    Report Number
    3005180920-2012-00062
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 6, 2012
    Report Date
    October 15, 2012
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFITCUP DM CUP 50: CODE (B)(4) / LOT 11510 (39 SHELLS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE 36 ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. VERSAFITCUP DM HIGHCROSS INSERT 28/50: CODE (B)(4) / LOT 111958 (36 LINERS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE 30 LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. THE RETRIEVED LINER WAS VISUALLY INSPECTED AND THE YELLOW COLOR AROUND THE SPHERE POLE WAS CONFIRMED, BOTH EXTERNALLY AND INTERNALLY. THEN THE LINER WAS CUT AND INTERNALLY IT WAS WHITE (STANDARD COLOR FOR THESE IMPLANTS). THE YELLOW COLOR IS PROBABLY DUE TO THE OXIDATION OF THE PE AND THE CAUSE IS UNK. HOWEVER, IT DOES NOT COMPROMISE THE MECHANICAL CHARACTERISTICS OF THE MATERIAL AS IT IS ONLY EXTERNAL. ON THE BASIS OF THE DATA COLLECTED, A DEVICE INVOLVEMENT IS HIGH UNLIKELY AND THIS KIND OF EVENT - DISLOCATION OF THE CUP - IS A KNOWN COMPLICATION OF A TOTAL HIP REPLACEMENT.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO LOOSENING/DISLOCATION OF THE CUP 6 MONTHS AFTER PRIMARY SURGERY. AFTER REVISION SURGERY THE HC LINER WAS INSPECTED AND WAS FOUND TO BE YELLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAFITCUP DOUBLE MOBILITY CUP ACETABULAR DM SHELL MEH MEDACTA INTERNATIONAL SA 111510

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention VERSAFITCUP DM HIGHCROSS LINER: (B)(4)| 510 (K) NUMBER: K092265| LOT 111958