BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING

    MDR report key: 6340558 · Received February 17, 2017

    Report

    Report Number
    0001825034-2017-00721
    Event Type
    Injury
    Date Received
    February 17, 2017
    Date of Event
    January 25, 2017
    Report Date
    February 15, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. IN THE PACKAGE INSERT UNDER POSSIBLE ADVERSE EFFECTS, ITEM 10 STATES: FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT. MEDICAL PRODUCT - COMP PRIMARY STEM 16MM STD CATALOG #: 113656 LOT #: 110350, COMP LOCKING SCREW CATALOG #: 180501 LOT #: 710430, COMP NON-LCKNG SCREW CATALOG #: 180509 LOT #: 999860, COMP RVRS SHDR GLEN BSPLT CATALOG #: 115330 LOT #: 628500, COMP NON-LCKNG SCREW CATALOG #: 180508 LOT #: 979470, COMP RVS CNTRL SCR CATALOG #: 115381 LOT #: 345270, STD HMRL BRNG CATALOG #: XL-115366 LOT #: 340340, VERSA DIAL/COMPREHENSIVE STD T PR ADAPTOR CATALOG #: 118001 LOT #: 182190, COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE CATALOG #: 115326 LOT #: 484540 THIS IS 1 OF 5 REPORTS BEING FILED FOR THE SAME PATIENT (REFERENCE 1825034-2017-00721 - 00725).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO IMPLANT FRACTURE APPROXIMATELY 4 YEARS POST-IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122845 COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A 157340

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R SEE H10 SUMMARY