BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP ACETABULAR SHELL

    MDR report key: 1970239 · Received January 14, 2011

    Report

    Report Number
    3005180920-2010-00013
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    June 8, 2010
    Report Date
    January 11, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW. VERSAFITCUP ACETABULAR SHELL REF. (B)(4) LOT. 03-0928. VERSAFITCUP DM LINER - REF. (B)(4)/LOT. 03-0955. THE QUALITY AND MANUFACTURING DOCUMENTS (BATCH RECORD) WERE REVIEWED: LOT 03-0928 COMPRISES 31 ACETABULAR CUPS; LOT 03-0955 COMPRISES 53 MOBILE INSERTS. ALL VALUES WERE ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF MANUFACTURE. THE STERILIZATION CYCLES WERE PERFORMED ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. (B)(6). THIS IS THE FIRST CASE INVOLVING AN ACETABULAR SHELL AND A DOUBLE MOBILITY LINER BELONGING TO THESE LOT NUMBERS. CERAMIC BALL HEAD - REF. (B)(4)/LOT. 31102 (PRODUCT NOT MARKETED IN THE USA): THE CERAMIC BALL HEADS WERE MANUFACTURED BY (B)(4) AND DISTRIBUTED BY (B)(4): ALL THE (B)(4) PIECES OF THIS LOT WERE IMPLANTED IN (B)(4) WITHOUT ANY OTHER CLAIM REPORTED. THE STATUS OF WEAR OF THE RETRIEVED INSERT WAS VERIFIED: THE EXTERNAL AND INTERNAL SURFACES LOOKED SMOOTH AND NO SIGN OF FRICTION WITH THE OTHER COMPONENTS WAS OBSERVED. THE ONLY SIGN IS DUE TO THE EXTRACTION OF THE CERAMIC HEAD. THE DIMENSIONAL CONTROL OF THE PE LINER WAS PERFORMED: THE INTERNAL DIAMETER 28 AND THE SHAPE OF THE SPHERE WERE FOUND TO BE CONFORMING TO SPECIFICATIONS. THE EXTERNAL DIAMETER 50 WAS FOUND SLIGHTLY UPPER THE SPECIFICATION LIMIT. SUCH A NON CONFORMITY IS HIGH LIKELY DUE TO THE DEFORMATION OCCURRED DURING EXTRACTION OF THE BALL HEAD AND IT IS NOT CORRELATED WITH THE REASON OF THE REVISION SURGERY. IN THE POST OPERATION REPORT, WRITTEN BY THE SURGEON, THERE WERE NO EVIDENCES OF A POSSIBLE FAILURE OF THE DEVICES. THE EVENT IS THOUGHT TO BE NOT DEVICE RELATED.

    Description of Event or Problem · 1

    MEDACTA WAS INFORMED ABOUT A REVISION OF VERSAFITCUP DOUBLE MOBILITY IMPLANT, 6 YEARS AFTER THE PRIMARY SURGERY. THE ACETABULAR SHELL, THE LINER AND THE CERAMIC BALL HEAD WERE REMOVED DUE TO A GRANULOMA. NO LOOSENING OF THE FEMORAL COMPONENT WAS OBSERVED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAFITCUP ACETABULAR SHELL ACETABULAR SHELL MEH MEDACTA INTERNATIONAL SA 03-0928

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention VERSAFITCUP DM LINER: REF (B)(4), LOT 03-0955| CERAMIC BALL HEAD: REF. (B)(4), LOT. 31102