BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 22902789 · Received August 27, 2025

    Report

    Report Number
    3005180920-2025-00809
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    August 1, 2025
    Report Date
    August 27, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: ABOUT 3 YEARS AFTER PRIMARY CEMENTLESS THA, A DISLOCATION OCCURS FOR UNREPORTED REASONS AND, DURING THE ATTEMPT AT CLOSED REDUCTION, THE HEAD IS SEPARATED FROM THE STEM. AT THIS POINT, CLOSED REDUCTION IS NO LONGER POSSIBLE AND A NEW SURGERY IS REQUIRED. THE MANIPULATION AND CONSEQUENT STRESSES LINKED TO AN ATTEMPT OF CLOSED REDUCTION IS NOT AMONG THE STANDARD ACTIVITIES FOR AN ARTIFICIAL HIP JOINT AND IT'S THEREFORE NORMAL THAT A DISASSEMBLY MAY BE CAUSED. NO REASON TO SUSPECT A DEFECTIVE DEVICE COMBINATION. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: FROM THE RECEIVED PARTS, NO PARTICULAR SIGNS OR DEFECTS WERE NOTICED IN THE FEMORAL HEAD AND POLYETHYLENE LINER. THE ATTEMPTS OF REDUCTION COULD HAVE STRESSED AND APPLIED TENSILE FORCE TO THE JUNCTION HEAD-STEM, RESULTING IN THE DECOUPLING OF THE TWO COMPONENTS. REGARDING THE FEMORAL HEAD DISLOCATION FROM THE LINER THAT OCCURRED PRIOR, THERE ARE NO EVIDENT SIGNS OR DEFECTS ON THE DEVICES; WE CANNOT DETERMINE THE ROOT CAUSE OF THE EVENT WITH THE PROVIDED INFORMATION, AS MULTIPLE VARIABLES MAY HAVE CONTRIBUTED (LAXITY OF TISSUES, CUP POSITION, OR PARTICULAR MOVEMENTS OF THE LEG). BATCH REVIEWS PERFORMED ON 4 AUGUST 2025: BALL HEADS: MECTACER 01.29.209 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-M (K112115) LOT 2119467: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04/05/2022. EXPIRATION DATE: 18/04/2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: VERSAFITCUP CC TRIO 01.26.3644HCT FLAT PE HC LINER Ø36/E LOT 2206932 (K120531): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11/05/2022. EXPIRATION DATE: 22/04/2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. STEM: AMISTEM P 01.18.406 AMISTEM-P STD. SIZE 6 LOT 2115919 (K173794): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09/03/2022. EXPIRATION DATE: 27/02/2027. 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. BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED FOR THE INITIAL JOINT DISLOCATION, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE. THE SUBSEQUENT HEAD-STEM DISSOCIATION WAS ATTRIBUTED TO THE REDUCTION MANEUVERS PERFORMED AFTER THE DISLOCATION. EXCESSIVE TRACTION OR IMPROPER TECHNIQUE DURING HIP PROSTHESIS REDUCTION CAN GENERATE FORCES EXCEEDING THE TAPER LOCK BETWEEN THE HEAD AND NECK, RESULTING IN DISSOCIATION.

    Description of Event or Problem · 0

    ABOUT 2 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT EXPERIENCED JOINT LUXATION IN EXTENSION. DURING REDUCTION ATTEMPTS PERFORMED AT THE EMERGENCY ROOM ON (B)(6) 2025, THE HEAD DISLOCATED FROM THE STEM. REVISION SURGERY WAS THEN CARRIED OUT ON (B)(6) 2025. ONLY LINER AND HEAD REVISED (HEAD DIAMETER 32 WITH SLEEVE AND HOODED LINER). THE SURGEON NOTED THAT THE CUP WAS OVERSIZED AND THAT A FOOTPLATE HAD FORMED DISTALLY IN THE FEMORAL DIAPHYSIS FOLLOWING THE INITIAL IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250575 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER HEAD BIOLOX DELTA DIA.36 12/14-M LZO MEDACTA INTERNATIONAL SA 01.29.209 2119467 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention