BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 0DEG 38MM

    MDR report key: 2926222 · Received January 16, 2013

    Report

    Report Number
    9616680-2013-90138
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    K071082
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE REASON FOR THE STERILIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHARGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DR REVISED PT'S RIGHT HIP DUE TO ALTR. SERUM LEVELS: COBALT 4.1 CHROME 2.0 JOINT ASPIRATE LEVELS COBALT 120 CHROME 58.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23554 LRG TAP PRI MOD NCK 0DEG 38MM IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA 23327201

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention