BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X53

    MDR report key: 8394721 · Received March 6, 2019

    Report

    Report Number
    3005180920-2019-00122
    Event Type
    Injury
    Date Received
    March 6, 2019
    Date of Event
    February 4, 2019
    Report Date
    March 6, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWY
    UDI-DI
    07630030843778
    PMA / PMN Number
    K091967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 MARCH 2019: LOT 145525: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-OCT-2014. EXPIRATION DATE: 2019-09-30. 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 IMPLANT INVOLVED: BALL HEADS: COCR 01.25.011 COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K072857), LOT 166587: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAR-2017. EXPIRATION DATE: 2022-02-22. 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

    A REVISION SURGERY (WASHOUT AND CHANGE OF BIPOLAR HEAD AND FEMORAL HEAD) AFTER OVER A MONTH HAS BEEN SUCCESSFULLY PERFORMED FOR SUSPECTED INFECTION (PATHOGEN NOT YET CONFIRMED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187395 BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X53 BIPOLAR HEAD KWY MEDACTA INTERNATIONAL SA 145525 07630030843778

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention