BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P COLLARED

    MDR report key: 21685775 · Received March 25, 2025

    Report

    Report Number
    3005180920-2025-00223
    Event Type
    Injury
    Date Received
    March 25, 2025
    Date of Event
    February 24, 2025
    Report Date
    March 25, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720229
    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 (B)(6) 2025. LOT 2114340: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-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 WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: BALL HEADS: MECTACER 01.29.210 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-L (K112115) LOT 2011681: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAR-2021. EXPIRATION DATE: 2026-02-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CUP: MPACT 01.32.154MH ACETABULAR SHELL Ø54 MULTI-HOLE (K132879) LOT 2106974: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-OCT-2021. EXPIRATION DATE: 2026-10-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT 2111809: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2021. EXPIRATION DATE: 2026-09-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.32.6515 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 15 (K103721) LOT 1908114: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2019. EXPIRATION DATE: 2024-10-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.32.6520 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 20 (K103721) LOT 2115334: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-NOV-2021. EXPIRATION DATE: 2026-NOV-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER 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

    REVISION SURGERY DUE TO INFECTION AT ABOUT 2 YEARS AND 10 MONTHS POST PRIMARY. THE CUP AND STEM WERE LOOSE DUE TO THE INFECTION. ALL DEVICES REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093408 AMISTEM-P COLLARED STEM: AMISTEM-P COLLARED 01.18.433 AMISTEM-P COLLARED STD. SIZE 3 LZO MEDACTA INTERNATIONAL SA 01.18.433 2114340 07630040720229

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention