BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LK SCR 3.5HEX 4.75X20 ST

    MDR report key: 8222147 · Received January 7, 2019

    Report

    Report Number
    0001825034-2018-11352
    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 -11338, 0001825034 -2018 -11351, 0001825034 -2018 -11352, 0001825034 -2018 -11353, 0001825034 -2018 -11354, 0001825034 -2018 -11355, 0001825034 -2018 -11356. (B)(4). CONCOMITANT MEDICALP 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
    14075 COMP LK SCR 3.5HEX 4.75X20 ST PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ZIMMER BIOMET, INC. N/A 239420

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R