BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 21974794 · Received May 7, 2025

    Report

    Report Number
    3005180920-2025-00375
    Event Type
    Injury
    Date Received
    May 7, 2025
    Date of Event
    April 8, 2025
    Report Date
    May 6, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809163
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16-APR-2025 LOT 174703: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2017. EXPIRATION DATE: 18-SEP-2022. 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. OTHER DEVICES INVOLVED: LINER: MPACT 01.32.3248HCT FLAT PE HC LINER Ø32/F (K103721) LOT 168468: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2017. EXPIRATION DATE: 14-FEB-2022. 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. STEM: AMISTEM-H PROX. COAT. 01.18.182 AMISTEM-H PROXIMAL COATING LAT. SIZE 2 (K161635) LOT 167939: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-FEB-2017. EXPIRATION DATE: 08-FEB-2022. 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, 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.

    Description of Event or Problem · 0

    AT ABOUT 7 YEARS AND 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1872793 MECTACER BIOLOX DELTA FEMORAL BALL HEAD BALL HEADS: MECTACER 01.29.205 MECTACER HEAD BIOLOX DELTA DIA.32 12/14-M LZO MEDACTA INTERNATIONAL SA 01.29.205 174703 07630030809163

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention