BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P COLLARED

    MDR report key: 20819445 · Received December 2, 2024

    Report

    Report Number
    3005180920-2024-01008
    Event Type
    Injury
    Date Received
    December 2, 2024
    Date of Event
    November 13, 2024
    Report Date
    December 2, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630040720212
    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 18-11-2024: LOT 2407449: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-06-2024. EXPIRATION DATE: 2029-06-03. 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. ADDITIONAL IMPLANTS REVISED: BATCH REVIEW PERFORMED ON 18-11-2024 FOR BALL HEADS: MECTACER 01.29.204 32MM BIOLOX DELTA HEAD S (K112115) LOT. 2400003: LOT 2400003: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-01-2024. EXPIRATION DATE: 2029-01-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 18-11-2024 FOR CUP: MPACT 01.32.148DHT ACETABULAR SHELL Ø48 TWO-HOLES T (K230011) LOT. 2339107: LOT 2339107: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-03-2024. EXPIRATION DATE: 2029-02-21. 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. BATCH REVIEW PERFORMED ON 18-11-2024 FOR LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT. 2306398: LOT 2306398: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-04-2023. EXPIRATION DATE: 2028-04-04. 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. INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    AT ABOUT 3 WEEKS FROM 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
    106725 AMISTEM-P COLLARED HIP AMISTEM-P COLLARED STD. SIZE 2 LPH MEDACTA INTERNATIONAL SA 01.18.432 2407449 07630040720212

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention