4,581 results
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61ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENSOETM
FDA Adverse Event
Malfunction
·ATTUNE MEDICAL·Product code PLA·April 4, 2023
DEPUY ATTUNE KNEE SYSTEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·November 1, 2018
ENSOETM
FDA Adverse Event
Injury
·ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL·Product code PLA·October 10, 2018
ENSO ETM UNIVERSAL BITEBLOCK
FDA Adverse Event
Injury
·ATTUNE MEDICAL / ADVANCED COOLING THERAPY, INC.·Product code PLA·June 4, 2024
PALACOS R+G
FDA Adverse Event
Injury
·HERAEUS MEDICAL GMBH·Product code MBB·March 10, 2025
PALACOS R+G
FDA Adverse Event
Injury
·HERAEUS MEDICAL GMBH·Product code MBB·March 10, 2025
ATTUNE CRS FEMORAL LT SZ 7 CEM
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code JWH·January 13, 2026
ATTUNE RP TIB BASE SZ 7 POR
FDA Adverse Event
Injury
·DEPUY IRELAND - 961667·Product code NJL·October 9, 2018
ATTUNE RP TIB BASE SZ 5 CEM
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code NJL·February 14, 2018
The ATTUNE Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code NJL·February 22, 2021
ATTUNE CR RP INSRT SZ 6 5MM
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code JWH·September 17, 2018
SMARTSET MV 40G - EO
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LOD·August 28, 2018
ATTUNE CR FEM RT SZ 6 NAR CEM
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code JWH·September 17, 2018
ATTUNE RP TIB BASE SZ 5 CEM
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code JWH·September 17, 2018
ATTUNE PS FB INSRT SZ 5 12MM
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code JWH·August 28, 2018
SMARTSET MV 40G - EO
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LOD·August 7, 2018
ATTUNE FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code JWH·February 22, 2021
UNKNOWN KNEE CONSTRUCT ATTUNE
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·November 20, 2025
The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code NJL·February 22, 2021
UNKNOWN KNEE TIBIAL INSERT
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code JWH·June 29, 2018