BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING

    MDR report key: 7159546 · Received January 3, 2018

    Report

    Report Number
    0001825034-2018-00005
    Event Type
    Injury
    Date Received
    January 3, 2018
    Date of Event
    August 30, 2016
    Report Date
    November 21, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    Z-1103-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. POLY BEARING AND TRAY ARE RETURNED FOR EVALUATION. VISUAL INSPECTION SHOWED THAT THE TRAY FRACTURED AT THE TAPER AND HAS WORN. NO DIMENSIONAL ANALYSIS WAS PERFORMED AS THE DEVICE HAS PHYSICAL DAMAGED. 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 AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: XL-115363, ARCOM XL 44-36 STD HMRL BRNG, 535110, 113655, COMP PRIMARY STEM 15MM STD, 210550, 115384, COMP RVS CNTRL SCR 6.5X40MM ST, 402180, 115330, COMP RVRS SHDR GLEN BSPLT +HA, 491150, 180502, COMP LOCKING SCREW 4.75X25MM, 015220, 118001, VERSA-DIAL/COMP TI STD TAPER, 327150, 115310, COMP RVRS SHLDR GLNSP STD 36MM, 340660, 180500, COMP LOCKING SCREW 4.75X15MM, 525040, 180501, COMP LOCKING SCREW 4.75X20MM, 660100, 180501, COMP LOCKING SCREW 4.75X20MM, 283910. 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.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS ABLE TO BE CONFIRMED VIA OPERATIVE NOTES. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. X-RAYS REVIEWED, FOUR VIEWS OF THE RIGHT SHOULDER TAKEN TODAY DO NOT SHOW A BROKEN PROSTHESIS AND THE TRUNNION FROM THE HUMERAL PROSTHESIS. ROOT CAUSE WAS DETERMINED TO BE DESIGN DEFICIENCY. 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 · 1

    IT WAS REPORTED BY THE PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT TOTAL RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY SIX (6) YEARS POST-OPERATIVELY DUE TO PAIN, CREPITUS, AND AUDIBLE CLUNKING ASSOCIATED WITH HUMERAL COMPONENT FRACTURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4198 COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING PROSTHESIS, SHOULDER PAO ZIMMER BIOMET, INC. N/A 846330

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R