BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC FLAT PE HC LINER 28/C

    MDR report key: 4619980 · Received March 18, 2015

    Report

    Report Number
    3005180920-2015-00040
    Event Type
    Injury
    Date Received
    March 18, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 MARCH 2015: LOT 122074: (B)(4) LINERS MANUFACTURED AND RELEASED ON 13 JULY 2012. EXPIRATION DATE: 2017-05-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR PROBLEM. ON (B)(4) 2015 THE MEDICAL AFFAIRS MADE THE FOLLOWING ANALYSIS: DISLOCATIONS ARE A DESCRIBED COMPLICATION OF TOTAL HIP ARTHROPLASTIES. IN THIS CASE, THE AVAILABLE INFORMATION IS NOT ENOUGH TO EVALUATE THE ORIGINAL POSITIONING OF THE COMPONENTS. HOWEVER, DISLOCATION IS ALWAYS ASSOCIATED TO AN INTRAOPERATIVE PROBLEM, POSSIBLY DUE TO DIFFICULT LOCAL SITUATIONS ENCOUNTERED, SUCH AS DIFFICULT ANATOMY OR UNFORESEEN COMPLICATIONS. IN THIS CASE FROM THE POSTOPERATIVE IMAGE IT SEEMS THAT THE REPOSITIONING OF THE COMPONENTS (WHICH CANNOT BE EVALUATED BY ITSELF) WAS POSSIBLE WITH LITTLE ADDITIONAL DAMAGE TO THE PT ANATOMICAL STRUCTURE. ON 18 MARCH 2015 WE GOT THE CONFIRMATION THAT THE ITEMS WILL NOT RETURN.

    Description of Event or Problem · 1

    IMP REF# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185189 VERSAFITCUP CC FLAT PE HC LINER 28/C FLAT UHMWPE LINER, LZO, MEH LZO MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1