BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GLENOID

    MDR report key: 21009411 · Received December 23, 2024

    Report

    Report Number
    0001825034-2024-03034
    Event Type
    Injury
    Date Received
    December 23, 2024
    Date of Event
    December 2, 2024
    Report Date
    January 15, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D1; D2; D4; D10; G1; G3; G6; H1; H2; H3; H6. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS BELOW IN THE D10 NARRATIVE. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): UNKNOWN HUMERAL HEAD (UNKNOWN), UNKNOWN STEM (UNKNOWN). ASSOCIATED PRODUCT INFORMATION: (B)(6). THE REPORTED EVENT IS UNCONFIRMED. 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 THAT 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

    (B)(4). D10: ASSOCIATED PRODUCT INFORMATION, PART (LOT): - (B)(6) (903900) - (B)(6) (66590559) - (B)(6) (099800) - (B)(6) (66843787) - (B)(6) (66992928) - (B)(6) (66190017) - (B)(6) (66845066) - (B)(6) (66983462) - (B)(6) (66783842) - (B)(6) (66817582) - 20-8090-009-02 (67070103) - (B)(6) (66775292) - (B)(6) (67006924) - (B)(6) (65562537) THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE ZIMMER BIOMET FOR INVESTIGATION, AND THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SHOULDER ARTHROPLASTY PROCEDURE FOR AN UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2364466 UNKNOWN GLENOID SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| R H11| H11