BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER GLENESPHERE STD

    MDR report key: 10065026 · Received May 18, 2020

    Report

    Report Number
    0001825034-2020-02015
    Event Type
    Injury
    Date Received
    May 18, 2020
    Date of Event
    September 4, 2019
    Report Date
    July 29, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    K080642
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G4, G7, H2, H3, H6, H10 MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: REVISION PROCEDURE NOTES: -BROKEN HUMERAL TRAY MORSE TAPER IDENTIFIED WHICH HAD TAKEN A PORTION OF THE METAL FROM THE MID PORTION OF THE TRAY -DURING TRIALING, THE STABILITY OF THE CUP WAS SUBOPTIMAL, SO THE DECISION WAS MADE TO REVISE THE GLENOID COMPONENT -DURING THE PROCEDURE 36MM GLENOSPHERE AND BEARING ARE REPLACED WITH 40MM GLENOSPHERE AND BEARING. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING OF GLENOSPHERE RELATED TO THE REPORTED EVENT. SINCE IT UNKNOWN IF INSTABILITY HAS CONTRIBUTED TO THE FRACTURE OR VICE VERSA A DEFINITE ROOT CAUSE CAN'T BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). COMMON DEVICE NAME: PHX. CONCOMITANT MEDICAL DEVICES: COMP RVS HMRL TI TRAY 44MM, CAT#: 115340, LOT#: 680760; VERSA-DIAL/COMP TI STD TAPER, CAT#: 118001, LOT#: 739220; ARCOM XL 44-36 STD HMRL BRNG, CAT#: XL-115363, LOT#: 370900; COMP RVRS SHDR GLEN BSPLT +HA, CAT#: 115330, LOT#: 172630; COMP PRIMARY STEM 14MM STD, CAT#: 113654, LOT#: 007880; COMP RVS CNTRL SCR 6.5X30MM, ST CAT#: 115382, LOT#: 791300; COMP LOCKING SCREW 4.75X15MM, CAT#: 180500, LOT#: 199570; COMP LOCKING SCREW 4.75X30MM, CAT#: 180503, LOT#: 199610; COMP LOCKING SCREW 4.75X30MM, CAT#: 180503, LOT#: 402230. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 02013, 0001825034 - 2020 - 02014, 0001825034 - 2020 - 02016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 9 YEARS DUE TO PAIN AND DYSFUNCTION OF THE SHOULDER. DURING THE REVISION, A FRACTURED HUMERAL TRAY WAS IDENTIFIED WITH SOME INSTABILITY OF THE CUP. THE HUMERAL TRAY, GLENOSPHERE, AND BEARING WERE REPLACED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530934 COMPREHENSIVE REVERSE SHOULDER GLENESPHERE STD PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. NI 590020

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10