BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR COCR BALL HEAD 12/14 28 SIZE M 0

    MDR report key: 10264555 · Received July 13, 2020

    Report

    Report Number
    3005180920-2020-00416
    Event Type
    Injury
    Date Received
    July 13, 2020
    Date of Event
    June 16, 2020
    Report Date
    July 13, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805110
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2020. LOT 1906935: 130 ITEMS MANUFACTURED AND RELEASED ON 18-DEC-2019. EXPIRATION DATE: 2024-12-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 103 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON (B)(6) 2020. LINER: MPACT 01.26.2850MHC DOUBLE MOBILITY HC LINER Ø 50/28 (K092265) LOT. 1908426 LOT 1908426: 132 ITEMS MANUFACTURED AND RELEASED ON 10-JAN-2020. EXPIRATION DATE: 2024-12-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 81 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR EVENT REPORTED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729744 BALL HEADS: COCR COCR BALL HEAD 12/14 28 SIZE M 0 COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.012 1906935 07630030805110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention