BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SHOULDER SYSTEM NANO HUMERAL COMP

    MDR report key: 17818666 · Received September 26, 2023

    Report

    Report Number
    0001825034-2023-02213
    Event Type
    Injury
    Date Received
    September 26, 2023
    Date of Event
    January 25, 2018
    Report Date
    February 28, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MECHANICAL (G04) STEM. THE REPORTED EVENT OF PAIN IS CONFIRMED VIA JOINT/PROTHESIS REVIEW PER MMI. IMPINGEMENT AND RANGE OF MOTION COULD NOT BE CONFIRMED NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. RADIOGRAPHS WERE PROVIDED AND IDENTIFIED THE FOLLOWING: ANTEROSUPERIOR SUBLUXATION OF THE RIGHT SHOULDER ARTHROPLASTY. OSTEOPENIA. ACROMIOCLAVICULAR JOINT ARTHROSIS. OTHER THAN THE ARTHROPLASTY SUBLUXATION, WHICH COULD RESULT IN PAIN, NO OTHER IMPLANT CONCERNS ARE IDENTIFIED. THERE IS ADVANCED RIGHT ACROMIOCLAVICULAR JOINT ARTHROSIS WHICH COULD ALSO RESULT IN PAIN. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). (B)(6). D10 - MEDICAL PRODUCT: CATALOG #: 118001, VERSA-DIAL/COMP TI STD TAPE, LOT # 985080, CATALOG #: 113042, VERSA-DIAL 46X18X53 HUM HEAD, LOT # 238100, CATALOG #: 113954, MD HYBRID GLENOID BASE 4MM, LOT # 494700, CATALOG #: PT-113950, PT HYBRID GLEN POST REGENEREX, LOT # 279250. G2: UK. G4: THIS PRODUCT WAS MANUFACTURED BY ZIMMER BIOMET AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. ANYMORE. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN WARSAW, INDIANA MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K182516. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-02214, 0001825034-2023-02215, 0001825034-2023-02216, 0001825034-2023-02217 H3 OTHER TEXT : REMAINS IMPLANTED.

    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 THAT AN INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY WAS IMPLANTED APPROXIMATELY 8 YEARS AGO. THREE YEARS LATER THE PATIENT REPORTED SEVERE PAIN, DECREASED RANGE OF MOTION, IMPINGEMENT AND WAS PRESCRIBED NARCOTICS. A FEW WEEKS AGO, IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING UNUSUAL SHOULDER PAIN AND THE PATIENT WAS REFERRED TO PAIN MANAGEMENT CLINIC ON AN UNKNOWN DATE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832071 COMPREHENSIVE SHOULDER SYSTEM NANO HUMERAL COMP EXTREMITIES IMPLANT HSD ZIMMER BIOMET, INC. N/A 945850

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Other SEE H10.