BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT HIP NECK

    MDR report key: 2915558 · Received January 10, 2013

    Report

    Report Number
    9616680-2013-90088
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    October 1, 2011
    Report Date
    December 20, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PATIENT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE REPORT FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT HAS HAD PROBLEMS WITH THE IMPLANT SINCE HER INITIAL SURGERY IN (B)(6) 2011. PATIENT SAYS, HER HIP DISLOCATED FOR NO REASON LESS THAN ONE MONTH AFTER THE IMPLANTATION. PATIENT SAYS, THE PAIN WAS EXCRUCIATING. PATIENT HAD SURGERY IN (B)(6) 2011 TO REPAIR THE HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13521 UNKNOWN LEFT HIP NECK IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention