BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 28 SIZE L +3.5

    MDR report key: 6339357 · Received February 17, 2017

    Report

    Report Number
    3005180920-2017-00047
    Event Type
    Injury
    Date Received
    February 17, 2017
    Date of Event
    January 19, 2017
    Report Date
    February 17, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON (B)(6) 2017. LOT 160027: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2016. EXPIRATION DATE: 2021-02-23. 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. DOUBLE MOBILITY HC LINER Ø 56/28, CODE (B)(4), LOT. 162326 (K092265); (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2016. EXPIRATION DATE: 2021-06-27. 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. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN AT THIS TIME. THE SURGEON SWAPPED THE HEAD AN LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121524 COCR BALL HEAD 12/14 Ø 28 SIZE L +3.5 METALLIC BALL HEAD JDI MEDACTA INTERNATIONAL SA 160027

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention