BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING 44MM

    MDR report key: 7758329 · Received August 7, 2018

    Report

    Report Number
    0001825034-2018-06136
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    December 1, 2016
    Report Date
    January 16, 2019
    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
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AVAILABLE. THE COMPLAINT WAS CONFIRMED BASED ON THE MEDICAL RECORDS PROVIDED. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. ROOT CAUSE IS RELATED TO 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 · 0

    NO ADDITIONAL INFORMATION IS MADE AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 113647 COMP PRIMARY STEM 7MM STD 553200, XL-115363 ARCOM XL 44-36 STD HMRL BRNG 019320, 115310 COMP RVRS SHLDR GLNSP STD 36MM 242610, 180511 COMP NON-LCKNG SCREW 4.75X35MM 288050, 115330 COMP RVRS SHDR GLEN BSPLT +HA 177750, 118001 VERSA-DIAL/COMP TI STD TAPER 685290, 115383 COMP RVS CNTRL SCR 6.5X35MM ST 245440, 180504 COMP LOCKING SCREW 4.75X35MM 436280, 180511 COMP NON-LCKNG SCREW 4.75X35MM 852740. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A REVERSE TOTAL SHOULDER ARTHROPLASTY REVISION DUE TO PAIN AND A HUMERAL TRAY FRACTURE, APPROXIMATELY SEVEN (7) YEARS POST PRIMARY SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597538 COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING 44MM PROSTHESIS, SHOULDER PAO ZIMMER BIOMET, INC. N/A 257020

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R