BEUDAMED
    135 results · 35ms · Sources: EU EUDAMED, US FDA

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    MECTALIF ANTERIOR

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OVD·February 23, 2024

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 10, 2019

    AMISTEM C CEMENTED STEM SIZE 0 LAT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code JDI·December 19, 2014

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·April 11, 2024

    GMK PRIMARY FIXED PS TIBIAL INSERT SIZE 5 / 14 MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 27, 2015

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIYE 3/14 MM R E-CROSS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 31, 2024

    CUP: VERSAFITCUP ACETABULAR SHELL Ø 48

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·March 29, 2023

    VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 50

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 27, 2016

    Evolis-Femoral Sizer Posterior Reference The femoral sizer posterior reference is a manual orthopedic surgical instrument that is used to determine the trial size and set the external rotation. The femoral sizer is an alternate instrument that can be used in addition to the standard MIS femoral sizer. The Femoral Sizer Posterior Reference intended to be placed on the distal femoral cut and determine the trail size and set the external rotation in preparation for the cut blocks. The femoral sizer posterior reference is intended to be placed on the distal femoral cut and determine the trial size and set the external rotation in preparation for the cut blocks. Indications for Use for the Medacta Evolis Total Knee System are: The Evolis Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases: - Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis - Avascular necrosis of femoral condyle - Post traumatic loss of joint configuration - Primary implantation failure.

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code JWH·September 11, 2009

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·April 24, 2020

    GMK RESURFACING PATELLA SIE 1

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 1, 2017

    QUADRA H FEMORAL STEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·December 7, 2012

    Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0137 (54mm), 01.26.10.0138 (56mm), 01.26.10.0139 (58mm), 01.26.10.0140 (60mm), 01.26.10.0141 (62mm), 01.26.10.0142 (64mm). Designed for cementless use in total hip arthroplasty.

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code MEH·January 15, 2010

    AMIS TABLE

    FDA Adverse Event
    Malfunction ·MEDACTA USA·Product code FWX·August 26, 2015

    Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.

    FDA Enforcement
    Class II ·Terminated·Medacta Usa Inc·November 14, 2012

    Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.

    FDA Recall
    Terminated ·Medacta Usa Inc·Product code MEH·December 17, 2012

    AMISTEM H FEMORAL STEM SIZE 4 LAT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 21, 2014

    GMK FEMORAL CUTTING GUIDE SIZE 6

    FDA Adverse Event
    Malfunction ·MEDACATA INTERNATIONAL SA·Product code JWH·August 30, 2012

    QUADRA S STD FEMORAL STEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code JDI·October 20, 2009

    NEXTAR INFRARED CAMERA

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·September 10, 2021