BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS SHORT ANCHOR PLUG 12MM

    MDR report key: 8417576 · Received March 13, 2019

    Report

    Report Number
    0001825034-2019-00722
    Event Type
    Injury
    Date Received
    March 13, 2019
    Date of Event
    December 17, 2018
    Report Date
    March 20, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K062998
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED AS VISUAL INSPECTION OF THE RETURNED DEVICE. THE ANCHOR PLUG SHOWS THAT THE SHAFT HAS FRACTURED OFF. THE FRACTURED PIECE IS STILL ATTACHED TO THE SPINDLE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS/ ANOMALIES IDENTIFIED. 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 AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CPS NUT CO-CR-MO ALLOY, ITEM# 178512, LOT# 609460; CPS SM SHT SPDL W PINS 400LBF, ITEM# 178365, LOT# 036750; OSS REINFORCED YOKE, ITEM# 150493, LOT# 061650; SUTURATRICE 360LX TEST.ROT.50R, ITEM# 529150, LOT# 010370; CPS CENTERING SLEEVE 19MM, ITEM# 178541, LOT# 484310; UNKNOWN BEARING, ITEM# UNKNOWN, LOT# 721520; UNKNOWN POLY SLEEVE, QUANTITY: 3; UNKNOWN POLY PIN, QUANTITY: 1. REPORT SOURCE - (B)(6). THE PRODUCT HAS BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL KNEE ARTHROPLASTY AND SUBSEQUENTLY THE PATIENT WAS REVISED DUE TO IMPLANT FRACTURE. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209545 CPS SHORT ANCHOR PLUG 12MM PROSTHESIS, KNEE KWA ZIMMER BIOMET, INC. N/A 347370

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R