BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE TIBIAL COMPONENT

    MDR report key: 8146974 · Received December 10, 2018

    Report

    Report Number
    0001822565-2018-06749
    Event Type
    Injury
    Date Received
    December 10, 2018
    Date of Event
    May 1, 2017
    Report Date
    October 1, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K013385
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT CANNOT BE CONFIRMED DUE TO LIMITED INFORMATION FROM THE CUSTOMER. NO DEVICES WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. MEDICAL RECORDS FOR THIS REVISION WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELATED DEVIATIONS / ANOMALIES IDENTIFIED. 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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORT: 0001822565-2018-06746, 0001822565-2018-06748, 0001822565-2018-06736, 0001822565-2018-06737, 0001822565-2018-06741, 0001822565-2018-06742, 0001822565-2018-06743, 0001822565-2018-06744, 0001822565-2018-06745. CONCOMITANT MEDICAL PRODUCTS: FEM SIZE F LEFT, ITEM# 00-5880-016-01, LOT# 62650040. NEXGEN CMTED STEM EXT 13X105MM, ITEM# 00-5988-018-13, LOT# 62820434. TM FEM META CONE, 35, LGE, LT, ITEM# 00-5450-022-35, LOT# 61830179. PRC AGMT BLOCK POST SZ F 10MM, ITEM# 00-5990-036-02, LOT# 61221088. PRC AGMT BLOCK DIST SZ F 5MM, ITEM# 00-5990-036-10, LOT# 63088967. PRC AGMT BLOCK DIST SZ F 5MM, ITEM# 00-5990-036-10, LOT# 63088967. PRC AGMT BLOCK POST SZ F 10MM, ITEM# 00-5990-036-02, LOT# 61248626. ART SURFACE 20MM FEM SZ F, ITEM# 00-5880-060-20, LOT# 62633501. BNE CMNT ANTIBIOTIC, ITEM# 5450-50-501, LOT# 8016678. SPACER CMNT RESTR FEM 18.5MM, ITEM# 12-9418 , LOT# 14ESM0277. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 WAS REVISED DUE TO PAIN, SWELLING, LACK OF RANGE OF MOTION, AND METALLOSIS. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985187 NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE KNEE TIBIAL COMPONENT PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 61079924

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R