BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS CNTRL 6.5X20MM ST/RST

    MDR report key: 7428617 · Received April 13, 2018

    Report

    Report Number
    0001825034-2018-02569
    Event Type
    Injury
    Date Received
    April 13, 2018
    Date of Event
    April 11, 2016
    Report Date
    July 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK132239
    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

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT(S): EP-115395, E1 44-36 RTNV +3 HMRL BRG, 888710; CP561548, CSTM BI-ANG REV SHLD 44MM TRAY, 730420; 115310, P RVRS SHLDR GLNSP STD 36MM, 414150; 115330, COMP RVRS SHDR GLEN BSPLT +HA, 493880; 118001, VERSA-DIAL/COMP TI STD TAPER, 149770; 180559, COMP NLK SCR 3.5HEX 4.75X25 ST, 224740; 180559, COMP NLK SCR 3.5HEX 4.75X25 ST, 191260; 180559, COMP NLK SCR 3.5HEX 4.75X25 ST, 073230; 180560, COMP NLK SCR 3.5HEX 4.75X30 ST, 375670. 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 REPORTS: 0001825034 - 2018 - 02565, 0001825034 - 2018 - 02566, 0001825034 - 2018 - 02567, 0001825034 - 2018 - 02568, 0001825034 - 2018 - 02564, 0001825034 - 2018 - 02570, 0001825034 - 2018 - 02571, 0001825034 - 2018 - 02572, 0001825034 - 2018 - 02573. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN, LOSS OF RANGE OF MOTION, AND LOOSENING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272363 COMP RVS CNTRL 6.5X20MM ST/RST PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 804220

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R