BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 42X27

    MDR report key: 7365115 · Received March 23, 2018

    Report

    Report Number
    3005180920-2018-00176
    Event Type
    Injury
    Date Received
    March 23, 2018
    Date of Event
    February 26, 2018
    Report Date
    March 23, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706612
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 27 FEBRUARY 2018 BY SALES REPRESENTATIVE THAT ATTEND THE REVISION SURGERY: NO ISSUE RELATED TO THE IMPLANTS. THE GLENOID COMPONENTS WERE POSITIONED "TOO" CRANIALLY AND CONSEQUENTLY THE GLENOSPHERE DID NOT FOLLOW / COVER THE LOWER PROFILE OF THE SCAPULA AND THIS COULD CAUSE A "MECHANICAL" LUXATION OF THE INVERSE (BONE CONTACT / INVERSE METAPHYSIS-LINER). BECAUSE OF THE DISLOCATION AND RUBBING OF THE GLENOSPHERE WITH THE MOST PROXIMAL PART OF THE INVERSE METAPHYSIS THE PATIENT HAS DEVELOPED A "PRINCIPLE OF METALLOSIS". CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS ON 09 MARCH 2018: RECURRENT DISLOCATION OF REVERSE SHOULDER ARTHROPLASTY. THIS EVENT SHOULD BE ASCRIBED TO A SOFT TISSUE DEFICIENCY. THE SURGEON DECIDED TO REPLACE LINER AND GLENOSPHERE 4 MONTHS AFTER IMPLANTATION TO REESTABLISH SOFT TISSUE TENSION. THE IMPLANTED COMPONENTS DID NOT MOBILIZE NOR DID THEY FAIL IN ANY WAY. THIS PROBLEM WAS NOT ORIGINATED BY A FAULTY DEVICE. PRELIMINARY INVESTIGATION PERFORMED BY R&D PRODUCT MANAGER ON 14 MARCH 2018 THE LUXATION MAY BE CAUSED BY LOW TENSION OF THE MUSCULAR STRUCTURES. THIS HYPOTHESIS APPEARS TO BE CONFIRMED BY THE CHANGE OF THE LINER FROM +0MM TO +6MM. THE METALLOSIS SEEMS TO BE PROVOKED BY THE CONTACT BETWEEN THE GLENOSPHERE AND THE REVERSE METAPHYSIS, AFTER IMPLANTS LUXATION BATCH REVIEW PERFORMED ON 21 MARCH 2018; REVERSE SHOULDER SYSTEM GLENOSPHERE 42X27 REFERENCE 04.01.0174; LOT 163805: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 DECEMBER 2016. EXPIRATION DATE: 2021-09-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+0MM REFERENCE 04.01.0125 (K1704529); LOT 173412: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 JUNE 2017. EXPIRATION DATE: 2022-05-31 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO ANTERIOR LUXATION AFTER 5 MONTHS FROM THE PRIMARY. NOTCHING BETWEEN THE GLENOSPHERE AND THE METAPHYSIS PROXIMAL PART CAUSED METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208467 REVERSE SHOULDER SYSTEM GLENOSPHERE 42X27 GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 163805 07630040706612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention