BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS SHORT ANCHOR PLUG 14MM

    MDR report key: 8608345 · Received May 14, 2019

    Report

    Report Number
    0001825034-2019-02189
    Event Type
    Injury
    Date Received
    May 14, 2019
    Date of Event
    April 19, 2019
    Report Date
    September 24, 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
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF PROVIDED RADIOGRAPHS AS WELL AS VISUAL INSPECTION OF THE RETURNED ANCHOR PLUG CONFIRMS THAT THE ANCHOR PLUG FRACTURED. THE FRACTURED PORTION IS SEEN ATTACHED TO THE SPINDLE CONNECTION. RETURNED DEVICE WAS SENT FOR SEM EVALUATION, WHICH STATES THAT THE FRACTURE SURFACE¿S ARTIFACTS SUGGEST A FATIGUE FRACTURE. XRF SCAN VERIFIES THAT THE MATERIAL IS CONFORMING THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: OSS 7CM SEGMENTAL FEMORAL LT, CATALOG: 150355, LOT: 968290; OSS CEMENTED IM STEM 9MMX90MM, CATALOG: 150358, LOT: 475610; OSS TIBIAL POLY BEARING 20MM, CATALOG: 150414, LOT: 996870; OSS MOD TIB BASEPLATE 71MM, CATALOG: 150422, LOT: 968750; OSS POLY TIBIAL BUSHING, CATALOG: 150476, LOT: 238810; OSS POLY FEMORAL BUSHINGS 2PK, CATALOG: 150477, LOT: 195730; OSS POLY LOCK PIN, CATALOG: 150478, LOT: 195670; OSS AXLE CATALOG, CATALOG: 150480, LOT: 243350; OSS REINFORCED YOKE, CATALOG: 150493, LOT: 461150; CPS NUT CO-CR-MO ALLOY, CATALOG: 178512, LOT: 939510; CPS TRANSVERSE PIN 6PK 40MM, CATALOG: 178529, LOT: 898500; CPS CENTERING SLEEVE 17MM, CATALOG: 178539, LOT: 303390; CPS LG SHT SPDL W PINS 600LBF, CATALOG: 178369, LOT: 501190; CPS/OSS 5CM TPR ADAPT W/OSS SC, CATALOG: 178711, LOT: 706750. REPORT SOURCE: FOREIGN - (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A REVISION OF A FEMORAL SALVAGE COMPRESS APPROXIMATELY SEVEN MONTHS POST IMPLANTATION SYSTEM DUE TO THE SPINDLE FRACTURING AND A LACK OF BONE INGROWTH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400567 CPS SHORT ANCHOR PLUG 14MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 541450

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R