BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHEAD RECON STEM IMPLANT 6MM COLLAR,SIZE 4

    MDR report key: 5319934 · Received December 22, 2015

    Report

    Report Number
    0008031020-2015-00604
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Date of Event
    July 26, 2013
    Report Date
    July 30, 2013
    Manufacturer
    STRYKER GMBH
    Product Code
    KWI
    PMA / PMN Number
    K023604-LTF
    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

    (B)(4).

    Description of Event or Problem · 1

    BREACH OF PACKAGE SEAL - (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 - SEAL TEST DATA OBTAINED FROM SUPPLIER AND INDICATES SATISFACTORY RESULTS

    Description of Event or Problem · 1

    BREACH OF PACKAGE SEAL - 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 - SEAL TEST DATA OBTAINED FROM SUPPLIER AND INDICATES SATISFACTORY RESULTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845559 RHEAD RECON STEM IMPLANT 6MM COLLAR,SIZE 4 ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS KWI STRYKER GMBH 22553901

    Patients

    Seq Age Sex Outcome Treatment
    1 Other