BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL 54 TWO-HOLES

    MDR report key: 10271040 · Received July 14, 2020

    Report

    Report Number
    3005180920-2020-00408
    Event Type
    Injury
    Date Received
    July 14, 2020
    Date of Event
    June 15, 2020
    Report Date
    July 14, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810824
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 26 JUNE 2020 LOT 165661: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-OCT-2016. EXPIRATION DATE: 2021-10-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. LOT 174523: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-DEC-2017. EXPIRATION DATE: 2022-11-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE OTHER SIMILAR REPORTED EVENT. LOT 174721: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2017. EXPIRATION DATE: 2022-11-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. LOT 171661: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2017. EXPIRATION DATE: 2022-06-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN 2 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734533 CUP: MPACT ACETABULAR SHELL 54 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 01.32.154DH 165661 07630030810824

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention