BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-P COLLARED

    MDR report key: 21135869 · Received January 13, 2025

    Report

    Report Number
    3005180920-2024-01159
    Event Type
    Injury
    Date Received
    January 13, 2025
    Date of Event
    December 18, 2024
    Report Date
    January 13, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720328
    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 (B)(6) 2024. LOT 2408154: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUNE-2024. EXPIRATION DATE: 2029-06-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE,(B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED AND REVISED: BATCH REVIEW PERFORMED ON (B)(6) 2024. BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT 2417339: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JULY-2024. EXPIRATION DATE: 2029-06-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. CUP: MPACT 01.32.158MHT ACETABULAR SHELL Ø58 MULTI-HOLE T (K230011) LOT 2338380: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUNE-2024. EXPIRATION DATE: 2029-06-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4)ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3652HCT FLAT PE HC LINER Ø36/G (K103721) LOT 2344541:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-JAN-2024. EXPIRATION DATE: 2028-12-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.43.0025 CANCELLOUS BONE SCREW Ø 6,5 L 25 (K200391) LOT 2410266: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2024. EXPIRATION DATE: 2029-05-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.43.0030 CANCELLOUS BONE SCREW Ø 6,5 L 30 (K200391) LOT 2410274: (B)(4)ITEMS MANUFACTURED AND RELEASED ON 22-MAY-2024. EXPIRATION DATE: 2029-05-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. SCREWS: MPACT 01.43.0030 CANCELLOUS BONE SCREW Ø 6,5 L 30 (K200391) LOT 2410276:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-MAY-2024. EXPIRATION DATE: 2029-05-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE,(B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS 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

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2024. SUBSEQUENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2024, THE SURGEON REVISED ALL IMPLANTS. PRESENTLY, ON (B)(6) 2024 THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON EXPLANTED ALL IMPLANTS AND PLACED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517390 AMISTEM-P COLLARED AMISTEM-P COLLARED LAT STEM SIZE 3 LZO MEDACTA INTERNATIONAL SA 01.18.443 2408154 07630040720328

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention