BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 36X24.5

    MDR report key: 10717728 · Received October 22, 2020

    Report

    Report Number
    3005180920-2020-00732
    Event Type
    Injury
    Date Received
    October 22, 2020
    Date of Event
    September 25, 2020
    Report Date
    December 18, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706568
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION: DISSOCIATION OF GLENOSPHERE FROM THE GLENOID BASEPLATE IN RSA FEW WEEKS AFTER PRIMARY SURGERY. ACCORDING TO THE REPORT, ONE OF THE BASEPLATE FIXING SCREWS WAS FOUND TO BE PROUD FROM THE BASEPLATE. SUCH CONDITION IS KNOWN TO PREVENT FULL SEATING OF THE GLENOSPHERE ON THE BASEPLATE AND THEREFORE THE SELF-UNSCREWING OF THE GLENOSPHERE FIXATION SCREW BECOMES QUITE LIKELY. THE POSSIBILITY THAT THE GLENOID FIXATION SCREW MOVED AFTER BEING INSERTED IS OF COURSE EXISTING BUT CANNOT BE VERIFIED AT THIS STAGE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20-OCT-2020: LOT 179110: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2018. EXPIRATION DATE: 14-MAR-2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. VISUAL INSPECTION WAS PERFORMED BY R&D PROJECT MANAGER: THE GLENOSPHERE SHOWS TWO MILD CIRCULAR MARKINGS ON THE BACKSURFACE PRESUMABLY DUE TO FRICTION WITH TWO PROTRUDING SCREWS. THE OUTER SURFACES OF GLENOSPHERE SCREW ARE PARTIALLY POLISHED. THIS IS DEEMED TO BE CAUSED BY FRICTION WITH THE INNER RECESS OF THE GLENOSPHERE AFTER IMPLANT MOBILIZATION. THE PE LINER IS MASSIVELY DAMAGED DUE TO FRICTION WITH THE SCAPULA AFTER MOBILIZATION OF THE GLENOSPHERE. THE INNER SCREW OF THE POLYAXIAL LOCKING SCREW IS PARTIALLY DAMAGED. IN DETAILS THE SUPERIOR RIM IS DEFORMED DOWNWARDS INDICATIVELY ALONG 150°. THE ROOT CAUSE OF SUCH A DEFORMATION IS DETERMINED TO BE THE CONTACT WITH THE GLENOSPHERE BACKSURFACE, WHICH MAY HAVE OCCURRED DUE TO A PROUD POSITIONING OF THE SCREW DURING THE PRIMARY SURGERY OR BACKING OF THE SCREW AFTER THE PRIMARY SURGERY. OTHER DEVICES INVOLVED IN THE EVENT: REVERSE SHOULDER SYSTEM 04.01.0159 GLENOID POLYAXIAL LOCKING SCREW - L22 LOT. 179970 (K170452). BATCH REVIEW PERFORMED ON 20-OCT-2020: LOT 179970: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2018. EXPIRATION DATE: 06-MAY-2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0151 GLENOID BASEPLATE Ø24.5X15 LOT. 1810997 (K170452) BATCH REVIEW PERFORMED ON 20-OCT-2020. LOT 1810997: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-FEB-2019. EXPIRATION DATE: 06-FEB-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO GLENOSPHERE DISSOCIATION FROM THE BASEPLATE 1 YEAR AND 3 MONTHS AFTER THE PRIMARY. DURING THE REVISION SURGERY ONE OF THE LOCKING SCREW WAS PROUD FROM THE GLENOID BASEPLATE AND THE SURGEON TRIED TO SCREW IT AGAIN BUT THE HEAD OF THE SCREW BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182601 REVERSE SHOULDER SYSTEM GLENOSPHERE 36X24.5 GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 04.01.0169 179110 07630040706568

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention