BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SYSTEM

    MDR report key: 25253489 · Received May 22, 2026

    Report

    Report Number
    3005180920-2026-00472
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    May 4, 2026
    Report Date
    May 22, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807787
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 07 MAY 2026: CUP: VERSAFITCUP CC TRIO 01.26.45.0054 VERSAFITCUP METALBACK CC TRIO D 54 (K103352) LOT 2336854: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-NOV-2023. EXPIRATION DATE: 2028-OCT-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. STEM: QUADRA-P COLLARED 01.12.164 QUADRA-P COLLARED STD. SIZE 4 (K192827) LOT 2346480: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-FEB-2024. EXPIRATION DATE: 2029-FEB-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. LINER: MECTACER 01.29.413 MECTACER INSERT BIOLOX DELTA XLW18 DIA.36/44G (NOT MARKETED IN US) LOT 2414802: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUN-2024. EXPIRATION DATE: 2029-MAY-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.208 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-S (K112115) LOT 2416429: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUN-2024. EXPIRATION DATE: 2029-06-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: LESS THAN 2 YEARS AFTER PRIMARY CEMENTLESS THA, THE PATIENT REPORTS PAIN AND AN INFECTION IS DETECTED. AS PER ATTACHED IMAGES, THE INFECTION HAS REACHED THE SURFACE OF THE IMPLANTS, WHICH ARE REPORTED TO HAVE BEEN FOUND SOLIDLY ATTACHED TO THE BONE. GIVEN THE GENERAL CONDITIONS OF THE PATIENT, IT IS VERY LIKELY THAT THE INFECTION ORIGINATED AT ANOTHER SITE AND THEN EXTENDED TO THE BONE/IMPLANT INTERFACE, BUT OF COURSE, WE CANNOT BE SURE OF THIS STATEMENT. AS THE DEVICES WERE SOLIDLY ATTACHED, WE SEE NO REASON TO SUSPECT THAT THEY CONTRIBUTED IN ANY WAY TO THE SITUATION THAT DETERMINED THEIR REMOVAL. INVESTIGATION PERFORMED BY MEDACTA HIP R&D PROJECT MANAGER: FROM THE INFORMATIONS AND THE IMAGES RECEIVED IT IS VISIBLE THE EXPLANTED STEM, CUP AND HEADS. ALL EXPLANTED IMPLANTS ARE COVERED WITH PATIENT BLOOD. IT IS NOT POSSIBLE TO IDENTIFY ANY ANOMALIES OF THESE IMPLANTS. THE ROOT CAUSE REMAIN UNKNOWN. ROOT CAUSE: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP REPLACEMENT ON (B)(6) 2024. APPROXIMATELY 8 MONTHS AGO, THE PATIENT REPORTED PAIN IN THE RIGHT HIP AREA. INVESTIGATIONS CONFIRMED A PROSTHETIC JOINT INFECTION. ON THE (B)(6) 2026, THE IMPLANTS WERE EXPLANTED, AND A TEMPORARY STEM AND CUP WERE IMPLANTED, WITH PLANNED REVISION SURGERY ONCE THE INFECTION IS RESOLVED. THE ORIGIN OF THE INFECTION IS NOT KNOWN. THE PATIENT HAS MULTIPLE RISK FACTORS (COMORBIDITIES SUCH AS DIABETES AND MORBID OBESITY) THAT MAKE FINDING THE ORIGIN OF THE INFECTION DIFFICULT. THE STEM AND CUP WERE WELL FIXATED, MAKING IMPLANT REMOVAL PROLONGED AND TECHNICALLY DEMANDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368239 VERSAFITCUP CC TRIO ACETABULAR SYSTEM VERSAFITCUP METALBACK CC TRIO Ø54 MM LZO MEDACTA INTERNATIONAL SA 01.26.45.0054 2336854 07630030807787

    Patients

    Seq Age Sex Outcome Treatment
    1