SMARTSET GMV 40G US EO

87MBB; 87LOD

This device is manufactured by DEPUY CMW - 9610921, DEPUY FRANCE SAS - 3003895575, DEPUY INTERNATIONAL, DEPUY IRELAND - 9616671, DEPUY ORTHOPAEDICS US.

The following problems were reported about this device:

Year Description Events/year Type
2024 Unspecified Infection 2 Patient
2024 Swelling/ Edema 2 Patient
2024 Pain 3 Patient
2024 Joint Laxity 2 Patient
2024 Insufficient Information 3 Patient
2024 Tear, Rip or Hole in Device Packaging 1 Device
2024 Loss of or Failure to Bond 2 Device
2024 Adverse Event Without Identified Device or Use Problem 3 Device
2023 Unspecified Infection 4 Patient
2023 Pain 4 Patient
2023 Loss of Range of Motion 2 Patient
2023 Joint Laxity 3 Patient
2023 Insufficient Information 4 Patient
2023 Fall 1 Patient
2023 Adhesion(s) 2 Patient
2023 Loss of or Failure to Bond 2 Device
2023 Chemical Problem 2 Device
2023 Adverse Event Without Identified Device or Use Problem 8 Device
2022 Swelling/ Edema 2 Patient
2022 Pain 2 Patient
2022 Loss of or Failure to Bond 9 Device
2022 Adverse Event Without Identified Device or Use Problem 3 Device
2021 Adverse Event Without Identified Device or Use Problem 2 Device
2019 Loss of or Failure to Bond 83 Device
2019 Loss of Osseointegration 5 Device
2019 Loosening of Implant Not Related to Bone-Ingrowth 2 Device
2019 Device Damaged Prior to Use 1 Device
2019 Adverse Event Without Identified Device or Use Problem 11 Device
2018 Packaging Problem 1 Device
2018 Malposition of Device 1 Device
2018 Loss of or Failure to Bond 171 Device
2018 Loss of Osseointegration 2 Device
2018 Loosening of Implant Not Related to Bone-Ingrowth 9 Device
2018 Loose or Intermittent Connection 57 Device
2018 Insufficient Information 35 Device
2018 Failure To Adhere Or Bond 11 Device
2018 Disconnection 2 Device
2018 Device Damaged Prior to Use 1 Device
2018 Crack 1 Device
2018 Appropriate Term/Code Not Available 5 Device
2018 Adverse Event Without Identified Device or Use Problem 11 Device
2017 Migration or Expulsion of Device 1 Device
2017 Loss of or Failure to Bond 172 Device
2017 Loss of Osseointegration 15 Device
2017 Loosening of Implant Not Related to Bone-Ingrowth 2 Device
2017 Loose or Intermittent Connection 23 Device
2017 Insufficient Information 13 Device
2017 Fracture 1 Device
2017 Failure To Adhere Or Bond 4 Device
2017 Break 3 Device
2017 Adverse Event Without Identified Device or Use Problem 10 Device
2016 Naturally Worn 1 Device
2016 Loss of or Failure to Bond 41 Device
2016 Loss of Osseointegration 2 Device
2016 Loose or Intermittent Connection 4 Device
2016 Failure To Adhere Or Bond 1 Device
2016 Device Slipped 1 Device
2016 Appropriate Term/Code Not Available 2 Device
2015 Tear, Rip or Hole in Device Packaging 1 Device
2015 Loss of or Failure to Bond 11 Device
2015 Loss of Osseointegration 3 Device
2015 Insufficient Information 1 Device
2015 Fracture 1 Device
2015 Device Slipped 1 Device
2014 Loss of or Failure to Bond 19 Device
2014 Insufficient Information 7 Device
2014 Adverse Event Without Identified Device or Use Problem 3 Device
2013 Loss of or Failure to Bond 1 Device
2013 Loss of Osseointegration 1 Device
2011 Pain 1 Patient
2011 Adverse Event Without Identified Device or Use Problem 1 Device
2010 Loss of or Failure to Bond 2 Device
2010 Adverse Event Without Identified Device or Use Problem 2 Device
2009 Adverse Event Without Identified Device or Use Problem 2 Device