BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE E LEFT

    MDR report key: 12196293 · Received July 20, 2021

    Report

    Report Number
    0001822565-2021-01965
    Event Type
    Injury
    Date Received
    July 20, 2021
    Date of Event
    June 21, 2021
    Report Date
    November 30, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00889024199149
    PMA / PMN Number
    K013385
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE AS FOLLOWS: -NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. -REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. -A DEFINITIVE 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: TRABECULAR METAL TIBIAL CONE, MEDIUM 31X31MM, CATALOG #: 00545001331, LOT #: 64700231; TIBIAL COMPONENT PRECOAT SIZE 2, CATALOG #: 00588000200, LOT #: 64146578; STEM EXTENSION STRAIGHT 12.7 MM DIA. X 30 MM LENGTH (COMBINED LENGTH 75 MM), CATALOG #: 00598801212, LOT #: 62762283; TRABECULAR METAL FEMORAL METAPHYSEAL CONE, 35MM, SMALL, LEFT, CATALOG #: 00545002035, LOT #: 64249422; STEM EXTENSION STRAIGHT LONG 14MM DIA X 155MM LENGTH(COMBINED LENGTH 200MM), CATALOG #: 00598801114, LOT #: 63240767; PRC AGMT BLOCK DIST SZ E 10MM, CATALOG #: 00-5990-035-20, LOT #: 62708077; PRC AGMT BLOCK DIST SZ E 10MM, CATALOG #: 00-5990-035-20, LOT #: 63789533; PRC AGMT BLOCK DIST SZ E 5MM, CATALOG #: 00-5990-035-01, LOT #: 63832525; PRC AGMT BLOCK DIST SZ E 5MM, CATALOG #: 00-5990-035-01, LOT #: 64630746; THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS REQUESTED FROM HOSPITAL AND NOT RETURNED . THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REFERENCE REPORT: 0001822565 - 2021 - 01942, 0001822565 - 2021 - 01943. INVESTIGATION INCOMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT WAS REVISED DUE TO HINGE POST WAS DISLOCATED FROM ROTATING HINGE KNEE FEMORAL HINGE AND ARTICULAR SURFACE WAS DISLOCATED FROM TIBIAL COMPONENT. ATTEMPTS HAVE BEEN MADE, BUT THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095468 NEXGEN FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE E LEFT PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 64366815 00889024199149

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R