BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 8222181 · Received January 7, 2019

    Report

    Report Number
    0001825034-2018-11351
    Event Type
    Injury
    Date Received
    January 7, 2019
    Date of Event
    June 26, 2018
    Report Date
    April 22, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K120121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. 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 INFORMATION AVAILABLE AT THE TIME OF THIS REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT(S): 0001825034 - 2018 - 11335, 0001825034 - 2018 - 11338, 0001825034 - 2018 - 11351, 0001825034 - 2018 - 11352, 0001825034 - 2018 - 11353, 0001825034 - 2018 - 11354, 0001825034 - 2018 - 11355, 0001825034 - 2018 - 11356. (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM # 115397 COMP RVS CNTRL 6.5X35MM ST/RST LOT 351970, 180550 COMP LK SCR 3.5HEX 4.75X15 ST LOT 115560, 010000589 COMP RVRS 25MM BSPLT HA+ADPTR LOT 180780, 180551 COMP LK SCR 3.5HEX 4.75X20 ST LOT 238420, 180551 COMP LK SCR 3.5HEX 4.75X20 ST LOT 238400, 115310 COMP RVRS SHLDR GLNSP STD 36MM LOT 128420, 113634 COMP PRIMARY STEM 14MM MINI LOT 213860, 115370 COMP RVS TRAY CO 44MM LOT 752390. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED TO ADDRESS PAIN WITH LOSS OF RANGE OF MOTION AND COMPONENT LOOSENING SECONDARY TO GLENOSPHERE DISASSOCIATION IN-VIVO. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14170 COMP RVRS 25MM BSPLT HA+ADPTR PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ZIMMER BIOMET, INC. N/A 180780

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R