BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO NO HOLE CEMENTLESS CUP Ø 58

    MDR report key: 5285790 · Received December 10, 2015

    Report

    Report Number
    3005180920-2015-00319
    Event Type
    Injury
    Date Received
    December 10, 2015
    Date of Event
    November 9, 2015
    Report Date
    March 10, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K122911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 04 DEC 2015 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING ANALYSIS CHECKING THE X-RAY: CEMENTLESS ACETABULAR CUPS ARE INSERTED WITH INTERFERENCE IN UNDER REAMED BONE. THE AMOUNT OF INTERFERENCE SHOULD BE JUDGED BY THE SURGEON AS IT IS PART OF THE INDIVIDUALLY VARIABLE ASPECTS OF TOTAL HIP REPLACEMENTS. MANUFACTURER SUGGESTS A TYPICAL PRESS FIT FOR "NORMAL" BONE CONDITIONS. HAND REAMING ALSO MEANS THAT THE SPHERICAL CAVITY IS NECESSARILY NOT PRECISE AND THEREFORE ACTUAL INTERFERENCE MAY VARY EVEN USING THE SAME REAMER AND THE SAME CUP SIZE. BONE QUALITY PLAYS A MAJOR ROLE. THE VERY LOW QUALITY XRAYS PROVIDED SHOW A PATIENT WITH A RATHER SCLEROTIC BONE. BONE SCLEROSIS IS OFTEN ASSOCIATED WITH ENHANCED FRAGILITY, AND THIS MAY BE THE ROOT CAUSE FOR THE PROBLEM. HOWEVER, PELVIC FRACTURE IS MOST LIKELY A SURGICAL PROBLEM, AND I DO NOT SEE ANY ELEMENT THAT MAKES ME SUSPECT A PRODUCT-RELATED PROBLEM. BATCH REVIEW PERFORMED ON 07 DECEMBER 2015: LOT 152663: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 AUGUST 2015. EXPIRATION DATE: 2020-07-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. IMPLANTED.

    Additional Manufacturer Narrative · 1

    ON 09 FEBRUARY 2016, IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON THE SAME DATE, THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    ACETABULUM FRACTURE DURING CUP IMPACTING. THE SURGEON HAD TO PUT ADDITIONAL SCREW INTO THE PELVIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817854 VERSAFITCUP CC TRIO NO HOLE CEMENTLESS CUP Ø 58 ACETABULAR CEMENTLESS SHELL LZO MEDACTA INTERNATIONAL SA 152663

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other