MOTO Partial Knee System - Medial 02.18.003RMRecalls & reported problems
Medacta International SA · Anatomical Femoral Component Cemented S3 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
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030895586), received between Oct 29, 2020 and Apr 14, 2026 — classified as 6 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 reports).
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
- Adverse Event Without Identified Device or Use Problem2
- Device Appears to Trigger Rejection2
- Appropriate Device Problem Term/Code Not Available1
- Migration1
Patient problems
- Pain3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Medical device site infection1
- Unspecified Infection1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryApr 14, 2026Device Appears to Trigger Rejection
REVISION SURGERY PERFORMED DUE TO INFECTION, 9 MONTHS AFTER THE PREVIOUS REVISION DUE TO INFECTION (MDR 2025-00628). THE SURGEON REMOVED THE FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY, AND IMPLANTED ANTIBIOTIC SPACERS IN THE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 24871678 ↗InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY 2 YEARS AND 1 MONTH POST PRIMARY FOR PAIN IN THE LATERAL COMPARTMENT AND THE CAUSE IS UNKNOWN. THE SURGEON CONVERTED THE PATIENT FROM A UNI TO A SPHERE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 19565506 ↗InjuryMar 13, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 4 YEARS AND 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED NEW PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 18892568 ↗InjuryMay 8, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
AT ABOUT 1 YEAR 6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATIENT FROM MOTO TO SPHERE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 16885914 ↗InjuryMar 24, 2023Migration; Migration
REVISION SURGERY PERFORMED AT ABOUT 1 MONTH AFTER THE PRIMARY DUE TO TIBIAL TRAY SUBSIDENCE. MOTO COMPONENTS HAVE BEEN SUCCESSFULLY REVISED WITH A GMK-SPHERE FEMORAL COMPONENT AND WITH GMK-REVISION TIBIAL COMPONENT, MEDIAL AUGMENTATION AND STEM. THE PATIENT HAS A VERY SOFT BONE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16610802 ↗InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem
THE PATIENT CAME IN REPORTING PAIN 11 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED ALL MOTO IMPLANTS TO SPHERE IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 10755026 ↗
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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