BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM-P COLLARED LAT STEM SIZE 5

    MDR report key: 13535309 · Received February 15, 2022

    Report

    Report Number
    3005180920-2022-00090
    Event Type
    Injury
    Date Received
    February 15, 2022
    Date of Event
    January 16, 2022
    Report Date
    February 15, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720342
    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 20-JANUARY-2022. LOT 2003964: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-AUG-2020. EXPIRATION DATE: 2025-AUG-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 20-JANUARY-2022: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT 2012923. LOT 2012923: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-APR-2021. EXPIRATION DATE: 2026-MAR-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT. LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT. 2010842. LOT 2010842: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-NOV-2020. EXPIRATION DATE: 2025-OCT-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT. SCREWS: MPACT 01.32.6525 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 25 (K103721) LOT. 2110796 LOT 2110796: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-SEP-2021. EXPIRATION DATE: 2026-SEP-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. SCREWS: MPACT 01.32.6525 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 25 (K103721) LOT. 2013778 LOT 2013778: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-FEB-2021. EXPIRATION DATE: 2026-JAN-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. CUP: MPACT 01.32.152DH ACETABULAR SHELL Ø52 TWO-HOLES (K132879) LOT. 2105760 LOT 2105760: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-AUG-2021. EXPIRATION DATE: 2026-AUG-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, 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
    584925 STEM: AMISTEM-P COLLARED LAT STEM SIZE 5 COLLARED AMISTEM-P LZO MEDACTA INTERNATIONAL SA 01.18.445 2003964 07630040720342

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention