BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHDR GLEN BSPLT +HA

    MDR report key: 8344045 · Received February 15, 2019

    Report

    Report Number
    0001825034-2019-00647
    Event Type
    Injury
    Date Received
    February 15, 2019
    Date of Event
    February 1, 2011
    Report Date
    February 14, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    K080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE PRODUCT CODE : PHX. UDI # N/A. CONCOMITANT MEDICAL PRODUCTS: HUMERAL TRAY ¿ CAT. NO. 115340, LOT NO. 457900; COMPREHENSIVE TAPER - CAT. NO. 118001, LOT NO. 761510; SCREW ¿ CAT. NO. 115381, LOT NO. 831360; FIXED SCREW ¿ CAT. NO. 180500, LOT NO. 219550; HUMERAL STEM ¿ CAT. NO. 113852, LOT NO. 924010; ADAPTER ¿ CAT. NO. 118001, LOT NO. 781510; CRS STANDARD BMT ¿ CAT. NO. 115310, LOT NO. 535460; HUMERAL BEARING ¿ CAT. NO. XL-115363, LOT NO. 702700; FIXED LOCKING SCREW ¿ CAT. NO. 180504, LOT NO. 852160; FIXED LOCKING SCREW ¿ CAT. NO. 180504, LOT NO. 905450; FIXED LOCKING SCREW ¿ CAT. NO. 180501, LOT NO. 971940. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2018 -05118, 0001825034 -2018 -05119, 0001825034 -2019 -00648, 0001825034 -2019 -00649, 0001825034 -2019 -00650. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES AND X-RAYS POST INITIAL SURGERY. AS PER THE X RAYS POST INITIAL SURGERY, SURGEON HAD PULLED THE GLENOSPHERE OFF OF THE GLENOID WITH LOSS OF ARTICULATIONS. AS PER THE REVISION SURGERY OPERATIVE NOTES, THE GLENOSPHERE WAS COMPLETELY PULLED OFF THE GLENOID. THE ACTUAL GLENOSPHERE LOCKING SCREWS REMAINED INTACT. THERE WAS A SMALL BONY DEFECT WHERE THE CENTRAL SCREW FIT INTO THE GLENOID WHERE IT PULLED OFF. THERE WAS A PROMINENCE OF A BROKEN SCREW. THIS WAS POSTERIOR MOST SCREW THAT WAS BROKEN AND PROTRUDED. REVIEW OF THE DHR FOUND THAT 4 PIECES BEING OUT OF SPEC ON THE TAPERS. THEY WERE ACCEPTED AFTER REWORK. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD COMPREHENSIVE REVERSE SHOULDER REVISION SURGERY IN LESS THAN TWO (2) MONTHS POST INITIAL SURGERY DUE TO DISASSOCIATION OF THE GLENOSPHERE WHICH MAY HAVE RESULTED INTO FRACTURE OF POSTERIOR MOST SCREW. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137293 COMP RVRS SHDR GLEN BSPLT +HA PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. N/A 550050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R