BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 42X27

    MDR report key: 11471403 · Received March 12, 2021

    Report

    Report Number
    3005180920-2021-00197
    Event Type
    Injury
    Date Received
    March 12, 2021
    Date of Event
    February 16, 2021
    Report Date
    May 26, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706612
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON APRIL 26TH 2021 THE DEVICE HAS BEEN RECEIVED. VISUAL INSPECTION PERFORMED BY R&D SHOULDER MANAGER: CIRCUMFERENTIAL SIGNS ARE VISIBLE ON THE CONVEX BACK SURFACE OF THE GLENOSPHERE, PROBABLY DUE TO FRICTION WITH A PERIPHERAL GLENOID SCREW. IT IS NOT POSSIBLE TO STATE WHETHER THE SCREW WAS POSITIONED PROUDLY FROM THE BASEPLATE AFTER THE PRIMARY SURGERY OR IT BACKED OUT IN THE FOLLOWING MONTHS. THE GLENOSPHERE SCREW SHOWS CIRCULAR SCRATCHES ON THE OUTER SURFACE. THE OUTER RIM OF THE LINER IS MASSIVELY DAMAGED. THIS IS PRESUMED TO HAVE OCCURRED FOLLOWING FRICTION WITH THE SCAPULA AFTER THE GLENOSPHERE DISSOCIATION.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 24.FEB.2021. LOT 189747: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAR-2019. EXPIRATION DATE: 2024-03-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0156 GLENOID BASEPLATE Ø27X35 (K170452) LOT. 179103. BATCH REVIEW PERFORMED ON 12.MAR.2021: LOT 179103: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-APR-2018. EXPIRATION DATE: 2023-04-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0126 HUMERAL REVERSE HC LINER Ø42/+3MM (K170452) LOT. 179983. BATCH REVIEW PERFORMED ON 24.FEB.2021: LOT 179983: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-APR-2018. EXPIRATION DATE: 2023-04-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT DUE TO INFECTION. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0163 GLENOID POLYAXIAL LOCKING SCREW - L38 (K170452) LOT. 179107. BATCH REVIEW PERFORMED ON 12.MARCH.2021: LOT 179107: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-APR-2018. EXPIRATION DATE: 2023-04-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0162 GLENOID POLYAXIAL LOCKING SCREW - L34 (K170452) LOT. 174748. BATCH REVIEW PERFORMED ON 12.MARCH.2021: 174748: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JAN-2018. EXPIRATION DATE: 2023-01-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH TWO SIMILAR REPORTED EVENTS. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 1901907. BATCH REVIEW PERFORMED ON 12.MARCH.2021: LOT 1901907: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2019. EXPIRATION DATE: 2024-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: REVISION OF RSA AFTER 1.5 YEARS DUE TO INFECTION. AT REVISION, THE GLENOSPHERE IS FOUND TO HAVE DETACHED FROM THE BASEPLATE, AND THE SURGEON REPORTEDLY SUSPECTS THAT ONE OF THE BASEPLATE SCREWS, NOT FULLY INSERTED, MAY HAVE PREVENTED THE GLENOSPHERE FROM REACHING THE FINAL SEAT AND ACHIEVING CORRECT LOCKING. THE RADIOGRAPHS SUPPLIED DO NOT ADD ANY USEFUL INFORMATION TO THE DETERMINATION OF THESE CIRCUMSTANCES.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY DUE TO INFECTION(SEPSIS) AND DISASSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE. METALLOSIS AND LINER DEFORMATION WAS VISIBLE DURING THE SURGERY. GLENOSPHERE, GLENOID POLYAXIAL LOCKING SCREW AND LINER WERE REMOVED. RE-LOCKING THE GLENOID POLYAXIAL LOCKING SCREW TO BE CERTAIN IT WAS LOCKED. PREVIOUSLY THIS PATIENT HAD COMPETITOR IMPLANTS IMPLANTED, BUT THE REASON OF ITS REMOVAL AND IMPLANTATION OF MEDACTA IMPLANTS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371327 REVERSE SHOULDER SYSTEM GLENOSPHERE 42X27 REVERSE SHOULDER GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 04.01.0174 189747 07630040706612

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention