BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS TRANSVERSE PIN 6PK 36MM

    MDR report key: 10147985 · Received June 12, 2020

    Report

    Report Number
    0001825034-2020-02313
    Event Type
    Injury
    Date Received
    June 12, 2020
    Date of Event
    January 23, 2020
    Report Date
    June 10, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304260535
    PMA / PMN Number
    K043547
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CPS SHORT ANCHOR PLUG CATALOG # 178558 LOT # 608690. CPS NUT CO-CR-MO ALLOY CATALOG # 178512 LOT # 987740. CPS/OSS 5CM TPR ADAPT W/OSS SC CATALOG # 178711 LOT # 779090. CPS SM SHT SPDL W PINS 800LBF CATALOG # 178367 LOT # 625750. CPS CENTERING SLEEVE 19MM CATALOG # 178541 LOT # 743560. OSS 3CM DIAPHYSEL SEGMENT CATALOG # 150464 LOT # 854640. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. X-RAY REVIEW INDICATES THERE IS A CLEARLY VISIBLE FRACTURE IN THE IMPLANT AT THE INTERFACE BETWEEN THE INTEROSSEOUS COMPONENT AND THE DIAPHYSIS COMPONENT WITHOUT SURROUNDING BONE. THE FRACTURE RESULTS IN MILD DISPLACEMENT LATERALLY OF THE DISTAL COMPONENT. ALSO NOTED AS A LINEAR HARDWARE COMPONENT WHICH IS DISPLACED MEDIAL TO THE CORTEX AT THE SITE OF THE HARDWARE FRACTURE. THE BONE QUALITY APPEARS OVERALL NORMAL, ALTHOUGH THERE HAS BEEN NO INTEGRATION OF THE BONE TO THE HARDWARE WITH WIDE GAPS BETWEEN THE HARDWARE AND ADJACENT BONE. 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO FRACTURED TRACTION BAR. ATTEMPTS FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612266 CPS TRANSVERSE PIN 6PK 36MM PROSTHESIS KNEE LPH ZIMMER BIOMET, INC. N/A 942320 00880304260535

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R