204 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Adverse Event
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GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 22, 2025
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 14, 2026
80FRN
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 4, 2014
UNK HIP FEMORAL HEAD METAL ASR
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KXA·October 23, 2012
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 16, 2010
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 3, 2024
GMK
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 30, 2026
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 5, 2025
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 20, 2024
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 16, 2024
GMK-SPHERIKA FEMORAL COMPONENT SPHERIKA CEMENTED S3+L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 23, 2024
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 16, 2024
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 13, 2022
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 25, 2024
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 18, 2024
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 20, 2024
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 22, 2024
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 9, 2024
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 23, 2025
GMK
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 30, 2025