BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 10459904 · Received August 27, 2020

    Report

    Report Number
    3005180920-2020-00548
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    July 28, 2020
    Report Date
    August 27, 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 04 AUGUST 2020. LOT 177197: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-FEB-2018. EXPIRATION DATE: 2023-01-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 128 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 04 AUGUST 2020. BALL HEADS: BIPOLAR HEAD 25060.2850 BIPOLAR HEAD Ø28X50 (K091967) LOT. 167637. LOT 167637: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAR-2017. EXPIRATION DATE: 2022-02-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 10 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. NO MANUFACTURING ISSUE HAS BEEN DETECTED ANALYZING THE DOCUMENTS RECEIVED FROM THE MANUFACTURER.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE BALL HEAD FROM BIPOLAR HEAD. THE CAUSE OF THE DISLOCATION IS UNKNOWN, IT HAPPENED 2 YEARS AND 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924204 BALL HEADS: COCR COCR BALL HEAD 12/14 28 SIZE M 0 COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 01.25.012 177197 07630030805110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention