BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SYSTEM

    MDR report key: 20746318 · Received November 21, 2024

    Report

    Report Number
    3005180920-2024-00965
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    October 28, 2024
    Report Date
    November 21, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030810893
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04-NOV-2024: LOT 2318536: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-DEC-2023. EXPIRATION DATE: 2028-11-28. 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 DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 04-NOV-2024: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT 2404440: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MAR-2024. EXPIRATION DATE: 2029-02-14. 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. LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721) LOT 2241227: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-DEC-2022. EXPIRATION DATE: 2027-11-21. 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. STEM: SMS SOLID 01.36.152 SMS COLLARED SOLID STEM STD SIZE 12 (K203041) LOT 2244083: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-MAR-2023. EXPIRATION DATE: 2028-03-07. 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. SCREWS: MPACT 01.43.0030 CANCELLOUS BONE SCREW Ø 6,5 L 30 (K200391) LOT 2319076: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2023. EXPIRATION DATE: 2028-08-19. 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. SCREWS: MPACT 01.43.0035 CANCELLOUS BONE SCREW Ø 6,5 L 35 (K200391) LOT 2315740: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-AUG-2023. EXPIRATION DATE: 2028-07-23. 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.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF AN 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
    2013691 MPACT ACETABULAR SYSTEM MPACT ACETABULAR SHELL Ø58 TWO-HOLES LZO MEDACTA INTERNATIONAL SA 01.32.158DH 2318536 07630030810893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention