BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P STD STEM SIZE 8

    MDR report key: 19458398 · Received June 4, 2024

    Report

    Report Number
    3005180920-2024-00399
    Event Type
    Injury
    Date Received
    June 4, 2024
    Date of Event
    May 8, 2024
    Report Date
    June 4, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720076
    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 04 JUNE 2024: LOT 1901570: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-APR-2019. EXPIRATION DATE: 2024-04-23. 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 DEVICES INVOLVED BATCH REVIEW PERFORMED ON 04 JUNE 2024: BALL HEADS: MECTACER 01.29.208 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-S (K112115) LOT 2100269: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-APR-2021. EXPIRATION DATE: 2026-04-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CUP: MPACT 01.32.156MH ACETABULAR SHELL Ø56 MULTI-HOLE (K132879) LOT 2011721: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MARCH-2021. EXPIRATION DATE: 2026-02-24. 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 2102555: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-APR-2021. EXPIRATION DATE: 2026-03-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH OTHER TWO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.32.6530 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30 (K103721) LOT 2106836: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JUNE-2021. EXPIRATION DATE: 2026-06-10. 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 YEARS 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658753 AMISTEM-P STD STEM SIZE 8 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 1901570 07630040720076

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention