BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS SHORT ANCHOR PLUG 16MM

    MDR report key: 8661459 · Received June 2, 2019

    Report

    Report Number
    0001825034-2019-02391
    Event Type
    Injury
    Date Received
    June 2, 2019
    Date of Event
    April 30, 2019
    Report Date
    October 23, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K062998
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI - (B)(4). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE OF THE ISSUE IS ATTRIBUTED TO PATIENT'S NON-COMPLIANT ACTIVITY POST-OPERATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 04806, 0001822565 - 2019 - 04554.

    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: 178541 - CPS CENTERING SLEEVE 19MM ¿ 957050, 178512 - CPS NUT CO-CR-MO ALLOY ¿ 099480, 150483 - OSS SEGMENTAL STACKING ADAPTER ¿ 489440, 150411 - OSS TIBIAL POLY BEARING 14MM ¿ 738320, 150476 - OSS POLY TIBIAL BUSHING ¿ 195890, 150478 - OSS POLY LOCK PIN ¿ 367520, 151838 - OSS 5CM TAPERED DIAPH SEGMENT ¿ 703180, 178711 - CPS/OSS 5CM TPR ADAPT W/OSS SC ¿ 099520, 161093 - OSS SEG DSTL FEM 8.5CM LT ¿ 550570, 178365 - CPS SM SHT SPDL W PINS 400LBF ¿ 885870, 178527 - CPS TRANSVERSE PIN 6PK 32MM ¿ 995750. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT IS UNAVAILABLE BY HOSPITAL POLICY. 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 UNDERWENT KNEE REVISION APPROXIMATELY 3 WEEKS POST IMPLANTATION DUE TO BONE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454907 CPS SHORT ANCHOR PLUG 16MM PROSTHESIS, KNEE KWA ZIMMER BIOMET, INC. N/A 671460

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R