BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR HUMERAL HEAD Ø42 MM

    MDR report key: 9457205 · Received December 12, 2019

    Report

    Report Number
    3008021110-2019-00146
    Event Type
    Injury
    Date Received
    December 12, 2019
    Date of Event
    December 3, 2019
    Report Date
    December 12, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    KWT
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT#, NO ANOMALY WAS DETECTED ON A TOTAL OF (B)(4) HUMERAL HEADS MANUFACTURED WITH LOT# 1813567. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT#. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED ON (B)(6) 2019 DUE TO IMPLANT DISLOCATION. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. ACCORDING TO THE INFORMATION REPORTED, THIS PATIENT HAD A FRACTURE A FEW YEARS AGO THAT WAS PLATED BUT THEN FAILED, HENCE ANATOMIC SMR WAS IMPLANTED. IT WAS REPORTED THAT AT THAT TIME, TUBEROSITIES HAD NOT HEALED YET. WHEN SMR ANATOMIC DISLOCATED, THERE WAS NEARLY NO BONE BETWEEN THE HEAD AND THE STEM AS THE TUBEROSITIES HAD ERODED AND NOT HEALED AROUND THE ANATOMIC TRAUMA BODY. IT WAS REPORTED THAT THE PLAN WAS TO LEAVE THE WELL FIXED STEM IN SITU BUT IT EASILY PULLED OUT WHEN FIXED TO THE TRIAL REVERSE BODY. THEREFORE, THE SURGEON DECIDED TO UPSIZE TO A 16MM STEM. THE SURGEON NOTED THAT THE 15MM WAS POSSIBLY UNDERSIZED AND HAD BEEN ROTATING INSIDE THE HUMERAL CANAL AS THE CANAL WAS ALMOST SMOOTH HENCE USED CEMENT AROUND THE PROSTHESIS FOR TORSIONAL STABILITY. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256012 SMR HUMERAL HEAD Ø42 MM SMR HUMERAL HEAD Ø42 MM (KWT, HSD) KWT LIMACORPORATE SPA 1322.09.420 1813567

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention