BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GLENOID COMPONENT

    MDR report key: 10817366 · Received November 10, 2020

    Report

    Report Number
    0001822565-2020-03778
    Event Type
    Injury
    Date Received
    November 10, 2020
    Report Date
    December 31, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. INSUFFICIENT INFORMATION PROVIDED. UNABLE TO PERFORM A COMPATIBILITY CHECK. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. PRODUCTS WERE IMPLANTED SOMETIME IN (B)(6) 2020. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: UNKNOWN, ITEM NAME: UNKNOWN STEM, LOT NUMBER: UNKNOWN. ITEM NUMBER: UNKNOWN, ITEM NAME: UNKNOWN HEAD, LOT NUMBER: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2020 - 03777. 0001822565 - 2020 - 03779. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAS ONGOING PAIN AND DIFFICULTY AMBULATING POST-REVISION. PATIENT IS ALSO EXPERIENCING COMPLICATIONS DUE TO AN ALLERGIC REACTION OF NICKEL AND TITANIUM. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283700 UNKNOWN GLENOID COMPONENT PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other