BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GLENOID

    MDR report key: 20912419 · Received December 12, 2024

    Report

    Report Number
    0001822565-2024-03938
    Event Type
    Injury
    Date Received
    December 12, 2024
    Report Date
    February 20, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IT WAS FURTHER DISCOVERED THAT THIS IS NOT A REVISION PROCEDURE, THERE IS NO IMPLANT IN SITU. THE CUSTOM DEVICE THAT WAS REQUESTED WILL BE THE PATIENT'S INITIAL IMPLANTS. THEREFORE, THIS IS NOT A REPORTABLE EVENT AND THE PREVIOUS REPORTS SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 0

    (B)(4). UPDATED: B4, B5, D2, G3, H1, H2, H6, H11. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE COULD NOT 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.

    Additional Manufacturer Narrative · 0

    CMP (B)(4) G2: UK. H3: THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION OR NOT. ONCE THIS INFORMATION IS OBTAINED A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS FURTHER DISCOVERED THAT THIS IS NOT A REVISION PROCEDURE, THERE IS NO IMPLANT IN SITU. THE CUSTOM DEVICE THAT WAS REQUESTED WILL BE THE PATIENT'S INITIAL IMPLANTS. THEREFORE, THIS IS NOT A REPORTABLE EVENT AND THE PREVIOUS REPORTS SHOULD BE VOIDED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PMI GROUP THAT A PATIENT UNDERWENT LEFT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT ON AN UNKNOWN DAY FOR AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2146034 UNKNOWN GLENOID EXTREMITY IMPLANT KWS ZIMMER BIOMET, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other