BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LK SCR 3.5HEX 4.75X15 ST

    MDR report key: 8222104 · Received January 7, 2019

    Report

    Report Number
    0001825034-2018-11338
    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
    K080642
    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

    IT WAS DETERMINED THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. PLEASE VOID THIS SUBMISSION.

    Description of Event or Problem · 0

    IT WAS DETERMINED THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. PLEASE VOID THIS SUBMISSION.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT(S): 0001825034-2018-11335, 0001825034-2018-11351, 0001825034-2018-11352, 0001825034-2018-11353, 0001825034-2018-11354, 0001825034-2018-11355, 0001825034-2018-11356. UDI (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
    14147 COMP LK SCR 3.5HEX 4.75X15 ST PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ZIMMER BIOMET, INC. N/A 115560

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R