BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 22518249 · Received July 16, 2025

    Report

    Report Number
    3005180920-2025-00638
    Event Type
    Injury
    Date Received
    July 16, 2025
    Date of Event
    June 19, 2025
    Report Date
    July 16, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809132
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23 JUNE 2025. BALL HEADS: MECTACER 01.29.202 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-M (K112115) LOT. 2118285 : (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22/03/2022. EXPIRATION DATE: 03/03/2027. 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. ADDITIONAL COMPONENTS INVOLVED IN THE EVENT: STEM: QUADRA-P 01.12.124 QUADRA-P STD STEM SIZE 4 (K181254) LOT. 2114267 : (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09/02/2022. EXPIRATION DATE: 27/01/2027. 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. LINER: VERSAFITCUP DM 01.26.2856MHC DOUBLE MOBILITY HC LINER Ø28/DMH ( K092265 ) LOT. 2115566: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12/01/2022. EXPIRATION DATE: 19/12/2026. 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. CLINICAL EVALUATION A REVISION SURGERY WAS PERFORMED APPROXIMATELY THREE YEARS AFTER THE PRIMARY THA DUE TO A LATE PERIPROSTHETIC JOINT INFECTION, WHICH RESULTED IN SEPTIC LOOSENING AND STEM SUBSIDENCE. INFECTION IS A RECOGNIZED POTENTIAL ADVERSE EVENT FOLLOWING ANY SURGICAL PROCEDURE, INCLUDING THA. AT PRESENT, THERE IS NO EVIDENCE TO SUGGEST A CAUSAL RELATIONSHIP BETWEEN THE INFECTION AND THE IMPLANTED DEVICES. 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

    AFTER 2 YEARS AND 11 MONTHS, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM THAT WAS CAUSED FROM AN INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555105 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER HEAD BIOLOX DELTA DIA.28 12/14-M LZO MEDACTA INTERNATIONAL SA 01.29.202 2118285 07630030809132

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention