BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMP RVS TRAY +5MM CO 44MM

    MDR report key: 9384494 · Received November 27, 2019

    Report

    Report Number
    0001825034-2019-05392
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    November 3, 2019
    Report Date
    January 15, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304534148
    PMA / PMN Number
    K113069
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: CATALOG #: XL-115363, ARCOM XL 44-36 STD HMRL BRNG, LOT # 689070, CATALOG #: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, LOT # 697730, CATALOG #: 180550, COMP LK SCR 3.5HEX 4.75X15 ST, LOT # 716640, CATALOG #: 180552, COMP LK SCR 3.5HEX 4.75X25 ST, LOT # 887390, CATALOG #: 180552, COMP LK SCR 3.5HEX 4.75X25 ST, LOT # 887380, CATALOG #: 115310, COMP RVRS SHLDR GLNSP STD 36MM, LOT # 465470, CATALOG #: 12-113560, COMPR 10MM HUM FRACT STEM PPS, LOT # 264740, CATALOG #: 405889, COMP RVS 2.7MM DIA DRL, LOT # 962330, CATALOG #: 405800, COMP. REV SHLDR 9 IN STEINMANN, LOT # 787430, CATALOG #: 115395, COMP RVS CNTRL 6.5X25MM ST/RST, LOT # 762300. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE HAD BEEN DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-05390.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY ABOUT A MONTH AGO. SUBSEQUENTLY, PATIENT WAS REVISED ABOUT 20 DAYS LATER DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177404 COMP RVS TRAY +5MM CO 44MM PROSTHESIS SHOULDER KWS ZIMMER BIOMET, INC. N/A 201700 00880304534148

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R