BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P COLLARED

    MDR report key: 23411609 · Received October 29, 2025

    Report

    Report Number
    3005180920-2025-01053
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    October 7, 2025
    Report Date
    October 29, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630040720205
    PMA / PMN Number
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 15 OCTOBER 2025: STEM: AMISTEM-P COLLARED 01.18.431 AMISTEM-P COLLARED STD. SIZE 1 (K173794) LOT: 2434824: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-APR-2025. EXPIRATION DATE: 2030-04-03. 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 IMPLANTS INVOLVED, BATCH REVIEWS PERFORMED ON 15 OCTOBER 2025: LINER: VERSAFITCUP DM 01.26.2846MHC DOUBLE MOBILITY HC LINER Ø28/DMC (K241767) LOT: 2338169: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2023. EXPIRATION DATE: 2028-11-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.202 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-M (K112115) LOT: 2513905: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JUN-2025. EXPIRATION DATE: 2030-05-18. 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. CONCLUSIONS: 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 SURGEON NEEDED A DRAINAGE AT THE INCISION SITE 2 WEEKS POST-OP FOR INFECTION. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2686353 AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 1 LPH MEDACTA INTERNATIONAL SA 01.18.431 2434824 07630040720205

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention