BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING

    MDR report key: 7777903 · Received August 13, 2018

    Report

    Report Number
    0001825034-2018-06354
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    June 21, 2018
    Report Date
    February 8, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS CONFIRMED BASED ON THE RETURN DEVICES. VISUAL INSPECTION CONFIRMS THAT THE TRAY POST WAS FRACTURED AND THE RING LOCK APPEARED TO BE BENT, POSSIBLY FROM DISASSEMBLING THE BEARING FROM THE TRAY. X-RAYS WERE REVIEWED AND REVERSE RIGHT TOTAL SHOULDER ARTHROPLASTY WITH WHAT APPEARS TO BE A FRACTURE OF THE JUNCTION OF THE HUMERAL TRAY AND THE HUMERAL STEM WITHOUT DISLOCATION. SEM CONCLUDED THAT THE FRACTURE SURFACE ARTIFACTS SUGGEST A BENDING OVERLOAD FRACTURE OF THE TAPER LIKELY INITIATING SUPERIOR MOVING INFERIOR. THE XRF SCAN VERIFIES THE TRAY METAL WAS CONFORMING TO MATERIAL SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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

    NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT AT THIS TIME

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE PRODUCT CODE-PHX. MEDICAL DEVICES.: 115330 COMP RVRS SHDR GLEN BSPLT +HA 751750; 180502 COMP LOCKING SCREW 4.75X25MM 207020- QTY 2; 115381 COMP RVS CNTRL SCR 6.5X25MM ST 004160; 180507 COMP NON-LCKNG SCREW 4.75X15MM 524480 - QTY 2; 118001 VERSA-DIAL/COMP TI STD TAPER 047560; 115310 COMP RVRS SHLDR GLNSP STD 36MM 873640 ; XL-115363 ARCOM XL 44-36 STD HMRL BRNG 023490; UNKNOWN HUMERAL STEM. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVERSE RIGHT SHOULDER ARTHROPLASTY REVISION PROCEDURE DUE TO INSTABILITY FROM HUMERAL TRAY FRACTURE APPROXIMATELY SEVEN (7) YEARS POST-IMPLANTATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618090 COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 807820

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R