BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS SEGMENTAL FEMORAL

    MDR report key: 7113809 · Received December 13, 2017

    Report

    Report Number
    0001825034-2017-11164
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    January 25, 2017
    Report Date
    December 15, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS CLEANED WITH BETADINE SOLUTION AND RE-IMPLANTED. ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: OSS TIBIAL POLY BEARING CAT#:150410, LOT#:701360; OSS CEMENTED STEM CAT#: 150368, LOT#: 691040; OSS POLY TIBIAL BUSHING CAT#: 150368, LOT#: 691040; OSS POLY FEMORAL BUSHINGS CAT#: 150477, LOT#: 067100; OSS POLY LOCK PIN CAT#: 150478, LOT#: 446190; OSS AXLE CAT#: 150480, LOT#: 146210; OSS REINFORCED YOKE CAT#: 150493, LOT#: 918850; OSS ELLIP DIAPHYSEAL SEG CAT#: 150461, LOT#: 755520; OSS NON-MOD TIB PLATE LONG 63 CAT#: 150419, LOT#: 612080; OSS TIB BLK AUG 10X63/67 UNIV CAT#: 150426, LOT#: 896800; OSS TIB BLK AUG 10X63/67 UNIV CAT#: 150426, LOT#: 015450. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. 0001825034 - 2017 - 1164, 0001825034 - 2017 - 02326, 0001825034 - 2017 - 02326-1, 0001825034 - 2017 - 02326-2, 0001825034 - 2017 -1168. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED EIGHT YEARS AFTER INITIAL KNEE SURGERY DUE TO TIBIAL BEARING FRACTURE. THE METALLOSIS WAS FOUND ON THE TRUNNION OF THE FEMORAL STEM. THE METALLOSIS WAS CLEANED OFF OF THE STEM AND RE-IMPLANTED ALONG WITH THE DISTAL FEMORAL COMPONENT AFTER BEING SOAKED IN BETADINE SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892128 OSS SEGMENTAL FEMORAL PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 919810

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R