BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE HUMERAL TI TRAY 44MM

    MDR report key: 7779316 · Received August 13, 2018

    Report

    Report Number
    0001825034-2018-05023
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    June 27, 2013
    Report Date
    June 24, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO DEVICE WAS RETURNED FOR EXAMINATION. MEDICAL RECORDS WERE REVIEWED AND CONFIRMED DEVICE DISASSOCIATION AND DISLOCATION WITH ASSOCIATED METALLOSIS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. ROOT CAUSE REMAINS UNDETERMINED. 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.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    THE PATIENT WAS REVISED TO ADDRESS DISLOCATION, DISASSOCIATION, AND SUBSEQUENT METALLOSIS. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORTING.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4). UNIQUE IDENTIFIER (UDI) #: N/A. CONCOMITANT MEDICAL PRODUCTS: CATALOG # 115310, COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE STD 36 MM, LOT # 609790. CATALOG # 113648, COMPREHENSIVE PRIMARY STEM 8 MM STD, LOT # 104520. CATALOG # 118001, VERSA-DIAL/COMPREHENSIVE TI STANDARD TAPER, LOT # 201410. CATALOG # XL-115363, ARCOM XL 44-36 STANDARD HUMERAL BEARING, LOT # 011140. CATALOG # 115330, COMPREHENSIVE REVERSE SHOULDER BASEPLATE, LOT # 550050. CATALOG # 180501, FIXED LOCKING SCREW, LOT # 468580. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT TOTAL REVERSE SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION. DURING THE REVISION IT WAS NOTED THAT THE PATIENT HAD SIGNS OF METALLOSIS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620123 COMPREHENSIVE REVERSE HUMERAL TI TRAY 44MM PROSTHESIS, SHOULDER PAO ZIMMER BIOMET, INC. N/A 492370

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R