BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMODULAR SHOULDER HUMERAL HEAD

    MDR report key: 7277385 · Received February 16, 2018

    Report

    Report Number
    0001825034-2018-00945
    Event Type
    Injury
    Date Received
    February 16, 2018
    Date of Event
    August 1, 2016
    Report Date
    February 16, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    PK030710
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: MFR#0001825034-2018-00943, MFR#0001825034-2018-00944. IT IS UNKNOWN WHICH GLENOID IS IMPLANTED IN THE LEFT SHOULDER. LOT# 796750 OR 961790. STERILE DATE: (B)(6) 2010 OR (B)(6) 2012. IMP DATE: (B)(6) 2002. CONCOMITANT MEDICAL PRODUCTS: BIOMODULAR SHOULDER HUMERAL STEM PN11-113700 LN214910 OR 051420. BIOMODULAR SHOULDER PEGGED GLENOID PN113870 LN690580 OR 001000. BIOMODULAR CENTERING SLEEVE PN 113789, LN 924610. MFG DATE: JUN 05, 2000 OR OCT 04, 2002. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED TO A COMPREHENSIVE REVERSE SHOULDER APPROXIMATELY FOURTEEN (14) YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121437 BIOMODULAR SHOULDER HUMERAL HEAD PROSTHESIS, SHOULDER HSD ZIMMER BIOMET, INC. N/A SEE H10 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R