BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED LAT STEM SIZE 5

    MDR report key: 18109046 · Received November 10, 2023

    Report

    Report Number
    3005180920-2023-00891
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    October 20, 2023
    Report Date
    November 10, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720342
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 OCTOBER 2023. LOT 2248868: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-MAY-2023. EXPIRATION DATE: 2028-04-22. 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. ADDITIIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 27 OCTOBER 2023. BALL HEADS: MECTACER 01.29.213 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M 0 (K112115) LOT. 2314755. LOT 2314755: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUN-2023. EXPIRATION DATE: 2028-05-30. 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 01.32.4052HCT FLAT PE HC LINER Ø40/G (K122641) LOT. 2304473. LOT 2304473: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MARC-2023. EXPIRATION DATE: 2028-03-07. 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 01.38.060DH ACETABULAR SHELL Ø60 TWO-HOLE (K171966) LOT. 2242464. LOT 2242464: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-DEC-2022. EXPIRATION DATE: 2027-11-29. 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 01.43.0025 CANCELLOUS BONE SCREW Ø 6,5 L 25 (K200391) LOT. 2239074. LOT 2239074: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2023. EXPIRATION DATE: 2028-02-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO OTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. TWO ITEMS OF THE SAME LOT ARE INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    AT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS, PERFORMED A WASHOUT, AND REIMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1945186 STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED LAT STEM SIZE 5 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 2248868 07630040720342

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention