BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL/COMPREHENSIVE TI STANDARD TAPER

    MDR report key: 7785167 · Received August 15, 2018

    Report

    Report Number
    0001825034-2018-05118
    Event Type
    Injury
    Date Received
    August 15, 2018
    Date of Event
    February 1, 2011
    Report Date
    February 14, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    PK080642
    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 · 0

    (B)(4). 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. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). UNIQUE IDENTIFIER (UDI) #: N/A. CONCOMITANT MEDICAL PRODUCTS: HUMERAL TRAY ¿ CAT. NO. 115340, LOT NO. 457900; HYDROXYAPATITE POROUS COAT ¿ CAT. NO. 115330, LOT NO. 550050; 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. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034 - 2018 - 05119.

    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
    628732 VERSA-DIAL/COMPREHENSIVE TI STANDARD TAPER PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. N/A 761510

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R