BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE M 0

    MDR report key: 8064114 · Received November 13, 2018

    Report

    Report Number
    3005180920-2018-00882
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    October 14, 2018
    Report Date
    November 13, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805165
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 NOVEMBER 2018. LOT 165651: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 FEBRUARY 2017. EXPIRATION DATE: 2022-01-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL COMPONENT REVISED: LINER: CC E CC LIGHT 01.26.3244HCT FLAT PE HC LINER Ø 32 / E, LOT 172573: (B)(4) ITEMS; MANUFACTURED AND RELEASED ON 05 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE,(B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 10 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR AN INFECTION CASE. THE PATIENT HAD ALREADY UNDERGONE TO TWO WASHOUT BEFORE DETECTING THE INFECTION. THE PATHOGEN WAS FOUND TO BE STAPHYLOCOCCUS AUREUS. LINER AND HEAD SWAP WAS PERFORMED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904772 BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE M 0 COCR FEMORAL HEAD JDI MEDACTA INTERNATIONAL SA 165651 07630030805165

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention