BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOID BASEPLATE SMALL-R

    MDR report key: 9003992 · Received September 12, 2019

    Report

    Report Number
    3008021110-2019-00104
    Event Type
    Injury
    Date Received
    September 12, 2019
    Date of Event
    August 29, 2019
    Report Date
    September 12, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    KWS
    PMA / PMN Number
    K133349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BY CHECKING THE MANUFACTURING AND STERILIZATION CHARTS OF LOT#S INVOLVED, NO ANOMALY WAS FOUND ON THE OVERALL COMPONENTS MANUFACTURED AND STERILIZED WITH THESE LOT#/STER. THEREFORE, WE CAN ENSURE THAT ALL THE COMPONENTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKED. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO IMPLANT LOOSENING OCCURRED ON THE (B)(6) 2019. PRIMARY SURGERY WAS PERFORMED ON THE (B)(6) 2018. ACCORDING TO THE INFO REPORTED, MANY FACTORS CONTRIBUTED TO LOOSENING OF THE PEG AND OF THE GLENOID: BONE GRAFT HAS BEEN ABSORBED EARLY. GLENOID WAS IMPLANTED TOO HIGH. POSSIBLE INFECTION . PATIENT WAS NOT COMPLIANT: HE HAS NOT FOLLOWED POST OP REGIME AND WAS PLAYING GOLF AND CHOPPING WOOD AGAINST ADVICE. ALL THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR CEMENTLESS FINNED STEM, CODE 1304.15.180, LOT#1801372, STER.1800133 SMR REVERSE HUMERAL BODY, (NOT MARKED IN USA); SMR REVERSE HP LINER SHORT, (NOT MARKED IN USA) SMR CONNECTOR SMALL R, CODE 1374.15.305, LOT#1805077, STER.1800091 SMR REVERSE HP GLENOSPH. 44 MM, (NOT MARKED IN USA); SMR GLENOID PEG TT SMALL-R #L, CODE 1375.14.653, LOT#1802842, STER.1800073; SMR GLENOID BASEPLATE SMALL-R, CODE 1375.15.605, LOT#1712833, STER.1700141. SWAB ANALYSIS SHOWED INFECTION WAS NOT PRESENT. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799868 SMR GLENOID BASEPLATE SMALL-R SMR GLENOID BASEPLATE SMALL-R (KWS-KWT) KWS LIMACORPORATE SPA 1375.15.605 1712833

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention