BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINER

    MDR report key: 9934459 · Received April 8, 2020

    Report

    Report Number
    0001822565-2020-01219
    Event Type
    Injury
    Date Received
    April 8, 2020
    Report Date
    April 1, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    NI
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: MIA S. HAGEN, MD, SACHIN ALLAHABADI, MD, ALAN L. ZHANG, MD, BRIAN T. FEELEY, MD, TREVOR GRACE, MD, C. BENJAMIN MA, MD* (2019). A RANDOMIZED SINGLE-BLINDED TRIAL OF EARLY REHABILITATION VERSUS IMMOBILIZATION AFTER REVERSE TOTAL SHOULDER ARTHROPLASTY, JOURNAL OF SHOULDER AND ELBOW ARTHROPLASTY. VOLUME 29, ISSUE 3, P442-450, HTTPS://DOI.ORG/10.1016/J.JSE.2019.10.005. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2020 - 01215, 0001822565 - 2020 - 01217, 0001822565 - 2020 - 01220. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. UNABLE TO PERFORM A COMPATIBILITY CHECK. MEDICAL RECORDS WERE NOT PROVIDED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A JOURNAL ARTICLE THAT ONE PATIENT WITHIN THE DELAYED-THERAPY GROUP TO EXPERIENCE A DEEP VENOUS THROMBOEMBOLISM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400934 UNK LINER PROSTHESIS, EXTREMITIES HSD ZIMMER BIOMET, INC. NI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other