BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SYSTEM

    MDR report key: 21932981 · Received April 30, 2025

    Report

    Report Number
    3005180920-2025-00357
    Event Type
    Injury
    Date Received
    April 30, 2025
    Date of Event
    April 1, 2025
    Report Date
    April 29, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807572
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11-APR-2025. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2015. EXPIRATION DATE: 31-MAR-2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINCAL EVALUATION PERFORMED BY CLINICAL AFFAITS DEPARTMENT. A REVISION SURGERY WAS PERFORMED APPROXIMATELY 10 YEARS AFTER THE PRIMARY IMPLANTATION OF A TOTAL HIP ARTHROPLASTY. THE PATIENT PRESENTED WITH COMPLAINTS OF PAIN AND UNDERWENT A CLINICAL FOLLOW-UP. THE AVAILABLE X-RAY IMAGES REVEAL A REGION OF OSTEOLYSIS IN THE ACETABULAR AREA, LOCATED ABOVE THE CUP. THIS FINDING IS PARTIALLY OBSCURED BY AN INFORMATIONAL ARTIFACT FROM THE X-RAY ITSELF. ADDITIONALLY, A SEPARATE AREA OF OSTEOLYSIS IS NOTED IN THE TROCHANTERIC REGION. HOWEVER, SINCE THE REVISION INVOLVED ONLY THE ACETABULAR COMPONENT, IT CAN BE INFERRED THAT THE FEMORAL STEM REMAINED STABLE. THE UNDERLYING CAUSE OF THIS FINDING IS DIFFICULT TO DETERMINE BASED ON THE AVAILABLE INFORMATION. NO DEFINITIVE CAUSE FOR THIS ADVERSE EVENT CAN BE ESTABLISHED. VISUAL INSPECTION PERFORMED BY R&D DEPARTMENT. FROM THE RECEIVED PIECES, THE LINER APPEARED YELLOWED: NO PARTICULAR OR EVIDENT SIGNS WERE NOTICED, EXCEPT FOR THE PRESENCE OF A HOLE CREATED FOR REMOVAL. THE CERAMIC BALL HEAD PRESENTED SOME SIGNS ON ITS SURFACE. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. ADDITIONAL INVOLVED DEVICES. VERSAFITCUP CC TRIO 01.26.45.1152 ACETABULAR SHELL CC TRIO NO-HOLE Ø 52 (K103352) LOT. 150076 BATCH REVIEW PERFORMED ON 11-APR-2025. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2015. EXPIRATION DATE: 31-MAR-2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 38.49.7175.675.00 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 NOT MARKETED IN US.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED DUE TO PAIN AT ABOUT 10 YEARS FROM THE PRIMARY SURGERY. LINER AND BALL HEAD REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223466 VERSAFITCUP CC TRIO ACETABULAR SYSTEM FLAT PE HC LINER Ø 32 / E LZO MEDACTA INTERNATIONAL SA 01.26.3244HCT 150102 07630030807572

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention