BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 52

    MDR report key: 11782733 · Received May 6, 2021

    Report

    Report Number
    3005180920-2021-00356
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    September 7, 2019
    Report Date
    May 6, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860973
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 APRIL 2021: LOT 173596: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-NOV-2017. EXPIRATION DATE: 2022-10-25. NO ANOMALIES FOUND. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER REPORTED EVENT. ANOTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 15 APRIL 2021: LINER: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER 28/DMF (K092265)LOT 171729: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JULY-2017. EXPIRATION DATE: 2022-07-06. NO ANOMALIES FOUND POSSIBLY RELATED TO A REVISION SURGERY. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER REPORTED EVENT. STEM: AMISTEM-H PROX. COAT. 01.18.174 AMISTEM-H PROXIMAL COATING STD STEM SIZE 4 (K161635)LOT 177361: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-FEB-2018. EXPIRATION DATE: 2023-02-20. NO ANOMALIES FOUND. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER REPORTED EVENT. BALL HEADS: COCR 01.25.012 COCR BALL HEAD 12/14 Ø 28 SIZE M 0 (K072857)LOT 177197: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-FEB-2018. EXPIRATION DATE: 2023-01-24. NO ANOMALIES FOUND. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE COMPLAINT REPORTED FOR INTRA-PROSTHETIC DISLOCATION

    Description of Event or Problem · 1

    REVISION SURGERY 1 YEAR AND 5 MONTHS AFTER PRIMARY FOR REASON UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THE SURGERY WAS COMPLETED SUCCESSFULLY, ALL DEVICES REVISED. NO FURTHER INFORMATION ARE AVAILABLE FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681299 CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 52 ACETABULAR SHELL DOUBLE MOBILITY LPH MEDACTA INTERNATIONAL SA 01.32.152MB 173596 07630030860973

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention