BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 15402292 · Received September 12, 2022

    Report

    Report Number
    3005180920-2022-00702
    Event Type
    Injury
    Date Received
    September 12, 2022
    Date of Event
    August 19, 2022
    Report Date
    September 12, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805110
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31 AUGUST 2022 LOT 092712: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-DEC-2009. EXPIRATION DATE: 2014-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 31 AUGUST 2022. LINER: VERSAFITCUP DM 01.26.2856MHC DOUBLE MOBILITY HC LINER 28/DMH (K092265) LOT. 092656 LOT 092656: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-DEC-2009. EXPIRATION DATE: 2014-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A TUMOR AND THE SURGEON DECIDED TO CHANGE THE HEAD AND LINER 12 YEARS 6 MONTHS AFTER THE PRIMARY FOR REASONS UNKNOWN. THERE WERE NO ISSUES WITH ANY PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579621 BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE M 0 COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.012 092712 07630030805110

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention