MOTO Partial Knee System - Medial 02.18.004RMRecalls & reported problems
Medacta International SA · Anatomical Femoral Component Cemented S4 RM · Class 2 · Implant
All models of MOTO Partial Knee System - Medial (46)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630030895609), received between Jul 5, 2019 and Apr 30, 2026 — classified as 8 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available5
- Adverse Event Without Identified Device or Use Problem1
- Device Appears to Trigger Rejection1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Pain3
- Unspecified Infection2
- Implant Pain1
- Joint Laxity1
- Medical device site infection1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryApr 30, 2026Device Appears to Trigger Rejection
THE PATIENT HAD SIGNS OF KNEE INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 9 MONTHS POST PRIMARY THE SURGEON REMOVED ALL MOTO IMPLANTS (FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY) AND PLACED ANTIBIOTIC SPACERS UNTIL PERMANENT HARDWARE IS IMPLANTED IN A FUTURE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25039925 ↗InjuryNov 20, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
AT 5 YEARS AND 7 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMORAL COMPONENT AND THE CAUSE IS UNKNOWN THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 18171486 ↗InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT CAME IN REPORTING DISCOMFORT AND PAIN AND THE REASON IS UNKNOWN. ABOUT 1 YEAR AND 6 MONTHS, THE SURGEON REVISED THE PATIENT FROM A MOTO KNEE TO A TOTAL KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 17497350 ↗InjuryFeb 21, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN REPORTING PAIN DUE TO A TORN MENISCUS ON THE LATERAL SIDE AND THE CAUSE IS UNKNOWN. AT 1 YEAR AND 7 MONTHS FROM THE PRIMARY THE SURGEON REVISED THE INSERT, TIBIAL TRAY, AND FEMORAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 13567347 ↗InjuryFeb 1, 2022Appropriate Device Problem Term/Code Not Available
AT ABOUT 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL IMPLANTS, PERFORMED A WASHOUT AND IMPLANTED A TOTAL SEMI-COSTAINED SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 13415523 ↗InjuryMar 16, 2021Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN 3MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED MEDACTA FEMUR AND INSERT WITH ANTIBIOTIC CEMENT TO ACT AS A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS PATIENT CAME IN AND HAD THE SPACER REMOVED AND PERMANENT HARDWARE IMPLANTED ON (B)(6) 2021.
Patient problems: Unspecified Infection
MAUDE report 11493347 ↗InjuryFeb 10, 2021Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY AND THE CAUSE OF THE PAIN AND INSTABILITY WAS DUE TO LIGAMENTS THAT HAD LOOSENED OVER TIME. 3 YEARS AND 3 MONTHS AFTER PRIMARY THE SURGEON REVISED THE FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Laxity
MAUDE report 11307550 ↗InjuryJul 5, 2019Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN COMPLAINING OF PAIN 6 MONTHS AFTER PRIMARY AND THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON REVISED THE MEDACTA UNI-KNEE TO ANOTHER COMPANY'S TOTAL-KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 8764333 ↗
Other Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer devices
- LinkSymphoKnee 880-307/21WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls2 reports
- Scorpio 73-3710Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls1 report
- Scorpio 73-3110Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls0 reports
- Arthrex® AR-503-TTTEArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall14 reports
- Arthrex® AR-503-TTTJArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- ENGAGE 1-10011-300Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- Arthrex® AR-503-TTTGArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10003-400Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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