BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P COLLARED

    MDR report key: 21207092 · Received January 22, 2025

    Report

    Report Number
    3005180920-2024-01178
    Event Type
    Injury
    Date Received
    January 22, 2025
    Date of Event
    December 27, 2024
    Report Date
    January 22, 2025
    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 08-01-2024: LOT 2410450: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-09-2024. EXPIRATION DATE: 2029-08-18. 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 08-01-2024 ON BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 2421394: LOT 2421394: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-08-2024. EXPIRATION DATE: 2029-07-22. 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. BATCH REVIEW PERFORMED ON 08-01-2024 ON CUP: MPACT 01.32.158DHT ACETABULAR SHELL Ø58 TWO-HOLES T (K230011) LOT. 2338381: LOT 2338381: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-03-2024. EXPIRATION DATE: 2029-02-18. 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 08-01-2024 ON LINER: MPACT 01.32.3652HCT FLAT PE HC LINER Ø36/G (K103721) LOT. 2405630: LOT 2405630: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-04-2024. EXPIRATION DATE: 2029-03-05. 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 1 MONTH 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
    691598 AMISTEM-P COLLARED HIP CEMENTLESS STEM LPH MEDACTA INTERNATIONAL SA 01.18.432 2410450 07630040720212

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention