BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 2931761 · Received January 28, 2013

    Report

    Report Number
    0002249697-2013-00380
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    September 12, 2012
    Report Date
    February 12, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS A DUPLICATED OF FDA REF. # 9616680-2012-000806, STRYKER REF.# (B)(4), SUBMITTED ON 2012-(B)(4).

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN REJUVENATE MODULAR NECK. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. HOSPITAL POLICY.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT REVISION SURGERY FOLLOWING DIAGNOSIS OF ALTR. THE FOLLOWING MEASUREMENTS WERE RECORDED AT 22 MONTHS SINCE INDEX SURGERY: COBALT - 5.3; CHROMIUM - 0.5. THE PATIENT WAS REPORTED TO BE SYMPTOMATIC WITH TROCHANTERIC PAIN. INFECTION WAS NOT DIAGNOSED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT REVISION SURGERY FOLLOWING DIAGNOSIS OF ALTR. THE FOLLOWING MEASUREMENTS WERE RECORDED AT 22 MONTHS SINCE INDEX SURGERY: COBALT - 5.3; CHROMIUM - 0.5. THE PATIENT WAS REPORTED TO BE SYMPTOMATIC WITH TROCHANTERIC PAIN. INFECTION WAS NOT DIAGNOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36447 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention