BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DM CONVERTER ¿ TIN COATED

    MDR report key: 24738822 · Received March 31, 2026

    Report

    Report Number
    3005180920-2026-00272
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    March 8, 2026
    Report Date
    March 31, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630971256354
    PMA / PMN Number
    K211891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 MARCH 2026. LINER: MPACT DM 01.26.2846MHC DOUBLE MOBILITY HC LINER D 28/DMC (K241767) LOT 2510833: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JUL-2025. EXPIRATION DATE: 02-JUL-2030. 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: MPACT DM 01.32.3844CF DM CONVERTER E/DMC - TIN COATED (K211891) LOT 2308607: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2023. EXPIRATION DATE: 22-AUG-2028. 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. ROOT CAUSE:DISLOCATION IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY JOINT ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO PREVIOUS CASE HAS BEEN ADDRESSED TO A DEVICE DESIGN OR MANUFACTURING RELATED ROOT CAUSE.

    Description of Event or Problem · 0

    THE PATIENT HAD PRIMARY SURGERY ON (B)(6) 2020. ON (B)(6) 2026, THE PATIENT CAME IN DUE TO A DISLOCATION OF THE HEAD AND LINER AS THE RESULT OF A FALL. THE SURGEON REVISED THE 36MM HEAD AND D 36 LINER TO A 28MM HEAD AND D 28 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN PRESENTING PAIN DUE TO A DISLOCATION OF THE DM LINER AND DM CONVERTER. THE CAUSE IS UNKNOWN AS NO TRAUMA WAS REPORTED. THE SURGEON REVISED THE DM BIOLOX D 28 LINER TO A FACE CHANG 10° PE HD LINER D 36 AND REVISED THE 28MM BIOLOX DELTA HEAD M TO A 36MM BIOLOX DELTA HEAD XL. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803026 DM CONVERTER ¿ TIN COATED DM CONVERTER E/DMC - TIN COATED LZO MEDACTA INTERNATIONAL SA 01.32.3844CF 2308607 07630971256354

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention