BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS CNTRL 6.5X40MM ST/RST

    MDR report key: 14858993 · Received June 29, 2022

    Report

    Report Number
    0001825034-2022-01511
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    October 22, 2021
    Report Date
    August 10, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304677104
    PMA / PMN Number
    K193373
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01510, 0001825034-2022-01512, 0001825034-2022-01515. CONCOMITANT MEDICAL PRODUCTS: TEM#: 180553, COMP LK SCR 3.5HEX 4.75X30 ST; LOT#: 044810, ITEM#: 180552, COMP LK SCR 3.5HEX 4.75X25 ST; LOT#: 453060, ITEM#: 180550, COMP LK SCR 3.5HEX 4.75X15 ST; LOT#: 296340, ITEM#: 12-113560, COMPR 10MM HUM FRACT STEM PPS; LOT#: 438080, ITEM#: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR; LOT#: 010240, ITEM#: 115310, COMP RVRS SHLDR GLNSP STD 36MM; LOT#: 140920. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS DISCARDED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THIS REPORT WILL BE VOIDED AND RESUBMITTED AS IT IS LINKED TO AN INCORRECT DOCUMENT/DECISION TREE WITHIN OUR COMPLAINT HANDLING SYSTEM. THE MEDWATCH REPORT WILL BE REPORTED UNDER MFR NUMBER 0001825034-2022-01844.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A TWO STAGE REVISION ARTHROPLASTY OF THE LEFT SHOULDER PROSTHESIS APPROXIMATELY 16 MONTHS POST REVISION ARTHROPLASTY DUE TO INFECTION, WHICH CAUSED LOOSENING OF THE SCREWS AND LED BONE LOSS OF THE GLENOID. THE PHYSICIAN FEELS THAT THE INFECTION STARTED AFTER THE INITIAL SURGERY AND THAT IT HAS REMAINED UNTIL THIS TWO STAGE REVISION WHEN THE INFECTION WAS TREATED. NO ADDITIONAL PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846221 COMP RVS CNTRL 6.5X40MM ST/RST SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES KWS ZIMMER BIOMET, INC. 115398 941740 00880304677104

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R