BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GLENOID

    MDR report key: 15847674 · Received November 22, 2022

    Report

    Report Number
    0001822565-2022-03296
    Event Type
    Injury
    Date Received
    November 22, 2022
    Report Date
    November 30, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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: 0001822565-2022-03293; 0001822565-2022-03295. MEDICAL PRODUCTS: ITEM#: UNKNOWN, UNKNOWN HUMERAL HEAD; LOT#: *UNKNOWN; ITEM#: UNKNOWN, UNKNOWN HUMERAL STEM; LOT#: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. 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 ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-03293-1, 0001822565-2022-03295-1. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT SHOULDER ARTHROPLASTY APPROXIMATELY THIRTEEN (13) YEARS AGO. SUBSEQUENTLY, THE PATIENT HAS EXPERIENCED SEVERE PAIN OVER THE PAST YEAR. LAB TESTS INDICATE ELEVATED CHROMIUM AND COBALT LEVELS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS ALLEGED THAT THEY ARE GOING TO UNDERGO A FUTURE REVISION PROCEDURE. HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314099 UNKNOWN GLENOID SHOULDER PROSTHESIS/EXTREMITIES KWS ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention SEE H10 NARRATIVE