BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOID BASEPLATE 27X15

    MDR report key: 11473640 · Received March 12, 2021

    Report

    Report Number
    3005180920-2021-00191
    Event Type
    Injury
    Date Received
    March 12, 2021
    Date of Event
    February 5, 2021
    Report Date
    June 2, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706414
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D MANAGER THE BASEPLATE APPEARS TO GENERALLY HAVE HA RESIDUALS ON THE COATED SURFACE, WHILE SOME SPOTS PRESENT BONE RESIDUALS, FOLLOWING EARLY BONY RESPONSE. THE ARTICULAR SURFACE OF THE GLENOSPHERE IS PARTIALLY SCRATCHED DUE TO FRICTION WITH THE REVERSE METAPHYSIS FOLLOWING BASEPLATE MOBILIZATION AND SUBSEQUENT LUXATION. THE GLENOSPHERE SCREW AND THE GLENOID LOCKING SCREWS DO NOT SHOW ANY SIGNS OF DAMAGE. NO ACTION IS SUGGESTED.

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDACTA CLINICAL DIRECTOR: EARLY MOBILISATION OF THE GLENOID BASEPLATE IN PRIMARY RSA, FEW WEEKS AFTER INDEX SURGERY. THE ORIGINAL BASEPLATE HAD SHORT PEG, THIS CHOICE WAS MOST PROBABLY DONE TO PRESERVE BONE WITH A COMPROMISE ON HOLD, WHICH IS COMMON PRACTICE. NO REASON TO SUSPECT A FAULTY DEVICE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 FEBRUARY 2021: LOT 2001981: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-APR-2020. EXPIRATION DATE: 2025-04-15. 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 4 MONTHS AFTER PRIMARY FOR BASE PLATE LOOSENING. THE SURGEON REVISED SUCCESSFULLY THE PATIENT SHOULDER REPLACING THE GLENOIDS IMPLANTS AND THE HUMERAL REVERSE HC LINER. THE GLENOSPHERE WAS FOUND COUPLED TO THE BASEPLATE DURING THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368394 REVERSE SHOULDER SYSTEM GLENOID BASEPLATE 27X15 GLENOID BASEPLATE PHX MEDACTA INTERNATIONAL SA 04.01.0154 2001981 07630040706414

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention