BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 22 SIZE M 0

    MDR report key: 8009367 · Received October 26, 2018

    Report

    Report Number
    3005180920-2018-00832
    Event Type
    Injury
    Date Received
    October 26, 2018
    Date of Event
    August 28, 2018
    Report Date
    September 27, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805479
    PMA / PMN Number
    K080885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 OCTOBER 2018. LOT 152709: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 SEPTEMBER 2015. EXPIRATION DATE: 2020-07-31. 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. MPACT DM DOUBLE MOBILITY HC LINER 22.2/DMC REFERENCE 01.26.2246MHC. LOT 155392: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 NOVEMBER 2015. EXPIRATION DATE: 2020-11-10. 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 1 MONTH AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR AN INFECTION CASE. LINER AND HEAD SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850724 COCR BALL HEAD 12/14 Ø 22 SIZE M 0 COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 152709 07630030805479

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention