BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P COLLARED

    MDR report key: 20426054 · Received October 11, 2024

    Report

    Report Number
    3005180920-2024-00806
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    September 12, 2024
    Report Date
    October 11, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720311
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 AUG 2024. LOT 2007801: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2020. EXPIRATION DATE: 2025-11-26. 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. OTHER DEVICES INVOLVED: BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT 2405095: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAR-2024. EXPIRATION DATE: 2029-02-27. 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. CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES (K132879) LOT 2343856: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2024. EXPIRATION DATE: 2029-04-21. 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 FLAT PE HC LINER Ø36/E (K103721) LOT 2348564: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JAN-2024. EXPIRATION DATE: 2028-12-27. 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. SCREWS: MPACT CANCELLOUS BONE SCREW Ø 6,5 L 25 (K200391) LOT 2319119: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEPT-2023. EXPIRATION DATE: 2028-08-26. 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.

    Description of Event or Problem · 0

    AT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336022 AMISTEM-P COLLARED HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.442 2007801 07630040720311

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention