BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL 50 TWO-HOLES

    MDR report key: 10546260 · Received September 17, 2020

    Report

    Report Number
    3005180920-2020-00620
    Event Type
    Injury
    Date Received
    September 17, 2020
    Date of Event
    August 20, 2020
    Report Date
    September 17, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810763
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 AUGUST 2020: LOT 1907397: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-NOV-2019. EXPIRATION DATE: 2024-11-19. 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. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 26 AUGUST 2020. BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT. 1908987. LOT 1908987: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-FEB-2020. EXPIRATION DATE: 2025-02-03. 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. LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT. 1907429. LOT 1907429: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2019. EXPIRATION DATE: 2024-09-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. STEM: AMISTEM C 01.18.100 CEMENTED LAT STEM SIZE 0 (K103189) LOT. 181666. LOT 181666: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUN-2018. EXPIRATION DATE: 2023-06-06. 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 DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND REVISED WITH A COMPETITOR'S SYSTEM 16 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009663 CUP: MPACT ACETABULAR SHELL 50 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 01.32.150DH 1907397 07630030810763

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention