ATTUNE FB TIBIAL IMPACTOR

KNEE INSTRUMENT/TRIAL

This device is manufactured by DEPUY IRELAND - 9616671, DEPUY ORTHOPAEDICS US.

The following problems were reported about this device:

Year Description Events/year Type
2024 Insufficient Information 6 Patient
2024 Foreign Body In Patient 1 Patient
2024 No Apparent Adverse Event 1 Device
2024 Material Integrity Problem 1 Device
2024 Entrapment of Device 1 Device
2024 Device-Device Incompatibility 2 Device
2024 Device Contaminated During Manufacture or Shipping 1 Device
2024 Crack 5 Device
2024 Contamination /Decontamination Problem 1 Device
2024 Break 22 Device
2023 Insufficient Information 4 Patient
2023 Naturally Worn 1 Device
2023 Material Integrity Problem 2 Device
2023 Crack 3 Device
2023 Break 25 Device
2022 Naturally Worn 1 Device
2022 Crack 4 Device
2022 Break 41 Device
2019 Naturally Worn 1 Device
2019 Crack 9 Device
2019 Break 80 Device
2018 Use of Device Problem 1 Device
2018 Naturally Worn 3 Device
2018 Material Split, Cut or Torn 2 Device
2018 Material Deformation 1 Device
2018 Crack 13 Device
2018 Component Missing 1 Device
2018 Burst Container or Vessel 1 Device
2018 Break 187 Device
2018 Adverse Event Without Identified Device or Use Problem 1 Device
2017 Material Fragmentation 1 Device
2017 Insufficient Information 2 Device
2017 Fracture 3 Device
2017 Failure to Discharge 1 Device
2017 Crack 8 Device
2017 Break 204 Device
2017 Appropriate Term/Code Not Available 2 Device
2016 Fracture 1 Device
2016 Break 91 Device
2015 Material Separation 1 Device
2015 Break 22 Device
2010 Break 1 Device