BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COMPREHENSIVE REVERSE HUMERAL STEM

    MDR report key: 11244433 · Received January 28, 2021

    Report

    Report Number
    0001825034-2021-00279
    Event Type
    Injury
    Date Received
    January 28, 2021
    Report Date
    March 26, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B1 CORRECTION: THIS EVENT WAS ORIGINALLY REPORTED AS BOTH A SERIOUS INJURY AND MALFUNCTION. IT WAS FOUND TO BE SERIOUS INJURY ONLY. 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. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). RANGARAJAN, RAJESH MD, BLOUT, COLLIN K. BS, PATEL, VIKAS V. MD. (2020). EARLY RESULTS OF REVERSE TOTAL SHOULDER ARTHROPLASTY USING A PATIENT-MATCHED GLENOID IMPLANT FOR SEVERE GLENOID BONE DEFICIENCY. JOURNAL OF SHOULDER AND ELBOW SURGERY, 29, 139-148. HTTPS://DOI.ORG/10.1016/J.JSE.2020.04.024. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN VRS CAT#NI LOT#NI. UNK COMPREHENSIVE REVERSE GLENOSPHERE CAT#NI LOT#NI. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDRS ARE ASSOCIATED WITH THIS REPORT; PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2021 - 00277, 0001825034 - 2021 - 00278.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE RETRIEVED FROM THE JOURNAL OF SHOULDER AND ELBOW SURGERY (2020), WHICH STUDIED PATIENTS WHO UNDERWENT RTSA USING VRS, THAT ONE PATIENT WITH CHRONIC HEPATITIS C PRESENTED TO A LOCAL HOSPITAL WITH AN INFECTED PROSTHESIS ERODING THROUGH THE SKIN. HE UNDERWENT EMERGENT COMPONENT REMOVAL, IRRIGATION AND DEBRIDEMENT, AND ANTIBIOTIC SPACER PLACEMENT LESS THAN 3 MONTHS AFTER THE SURGICAL PROCEDURE AND WAS LOST TO FOLLOW-UP. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142760 UNKNOWN COMPREHENSIVE REVERSE HUMERAL STEM PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10