BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LATERAL ASSEMBLY, RADIAL HEAD IMPL ASSEMBLY,SIZE4

    MDR report key: 5319792 · Received December 22, 2015

    Report

    Report Number
    0008031020-2015-00601
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Date of Event
    July 13, 2013
    Report Date
    July 13, 2013
    Manufacturer
    STRYKER GMBH
    Product Code
    JDB
    PMA / PMN Number
    K060038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITH GUIDANCE FROM THE MDR POLICY BRANCH OF THE FDA, MDR REPORTED BY STRYKER (B)(4) AS A RESULT OF A RETROSPECTIVE LOOKBACK OF COMPLAINTS RESULTING FROM THE ACQUISITION OF ASSETS FROM (B)(4). DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY (B)(4) AND IMPLANTED PRIOR TO HOWMEDICA OSTEONICS CORP.¿S PURCHASE OF CERTAIN ASSETS OF (B)(4) ON AUGUST 1, 2014. STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON APRIL 1, 2015 AND HAS TAKEN THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING. DEVICE IS NOT AVAILABLE TO STRYKER.

    Additional Manufacturer Narrative · 1

    MANUFACTURING DATE WAS ADDED.

    Description of Event or Problem · 1

    LATERAL RHEAD PACKAGING BREACH. TWO DIFFERENT PACKAGES WERE INVOLVED. THE OUTER PACKAGING WAS INTACT FOR BOTH, BUT INNER PACKAGES WERE BREACHED. (B)(4) IS CURRENTLY CONDUCTING A RECOVERY OF PACKAGED PRODUCT ASSOCIATED WITH THE PACKAGING BREACH. THIS ACTIVITY WILL REPACKAGE (B)(4) PRODUCT WITH A (2) YEAR EXPIRATION DATE. CONCURRENTLY A NEW PACKAGE DESIGN IS UNDER VALIDATION.

    Description of Event or Problem · 1

    LATERAL RHEAD PACKAGING BREACH. TWO DIFFERENT PACKAGES WERE INVOLVED. THE OUTER PACKAGING WAS INTACT FOR BOTH, BUT INNER PACKAGES WERE BREACHED. SBI IS CURRENTLY CONDUCTING A RECOVERY OF PACKAGED PRODUCT ASSOCIATED WITH THE PACKAGING BREACH. THIS ACTIVITY WILL REPACKAGE SBI PRODUCT WITH A (2) YEAR EXPIRATION DATE. CONCURRENTLY A NEW PACKAGE DESIGN IS UNDER VALIDATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845564 LATERAL ASSEMBLY, RADIAL HEAD IMPL ASSEMBLY,SIZE4 PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED JDB STRYKER GMBH 16712

    Patients

    Seq Age Sex Outcome Treatment
    1 Other