BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P LAT STEM SIZE 2

    MDR report key: 19079928 · Received April 10, 2024

    Report

    Report Number
    3005180920-2024-00219
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    March 12, 2024
    Report Date
    April 10, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720113
    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 08 APRIL 2024. LOT 2114214: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-FEB-2022. EXPIRATION DATE: 2027-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 08 APRIL 2024: BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 (K112115) LOT 2312444: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-JUNE-2023. EXPIRATION DATE: 2028-05-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CUP: MPACT 01.32.156DH ACETABULAR SHELL Ø56 TWO-HOLES (K132879) LOT 2213426: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-SEP-2022. EXPIRATION DATE: 2027-09-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721) LOT 2301424: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MARCH-2023. EXPIRATION DATE: 2028-03-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.43.0030 CANCELLOUS BONE SCREW Ø 6,5 L 30 (K200391) LOT 2245829: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MARCH-2023. EXPIRATION DATE: 2028-02-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS AFTER 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
    418966 AMISTEM-P LAT STEM SIZE 2 HIP STEM LZO MEDACTA INTERNATIONAL SA 2114214 07630040720113

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention