MOTO Partial Knee System - Medial 02.18.IF4.08.RMRecalls & reported problems
Medacta International SA · Tibial insert fix S4 RM - 8mm · 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
- 7
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630030896101), received between Sep 19, 2018 and Aug 12, 2025 — classified as 6 injuries, 1 malfunction.
The most frequently reported specific device problem is “Microbial Contamination of Device” (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 Available3
- Adverse Event Without Identified Device or Use Problem2
- Microbial Contamination of Device1
- Positioning Problem1
Patient problems
- Unspecified Infection4
- Hematoma1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2025Positioning Problem; Positioning Problem
TIBIAL INSERT 8MM COULD NOT BE COUPLED WITH THE TIBIAL TRAY; 9MM INSERT WAS USED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO TIBIA RECUT NEEDED. THE SURGERY WAS PROLONGED BY ABOUT 20 MINUTES. DEVICES COUPLED IN BACKTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22781806 ↗InjuryJun 13, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 14675383 ↗InjuryJun 10, 2022Appropriate Device Problem Term/Code Not Available
THE SURGEON PLANS TO EXCHANGE THE EXISTING 10MM TIBIAL INSERT FOR A THICKER ONE DUE TO SOME VARUS/VALGUS INSTABILITY. REVISION SURGERY IS PLANNED FOR THE (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 14652251 ↗InjuryJan 25, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN 19 DAYS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 13340928 ↗InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem
THE PATIENT CAME IN 1 MONTH AFTER THE PRIMARY SURGERY FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT A HEMATOMA HAD DEVELOPED. THE CAUSE OF THE HEMATOMA IS UNKNOWN. THE SURGEON PERFORMED AN WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Hematoma
MAUDE report 11106976 ↗InjuryApr 23, 2020Microbial Contamination of Device
THE PATIENT CAME IN, 3 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 9989993 ↗InjurySep 19, 2018Adverse Event Without Identified Device or Use Problem
REVISION PERFORMED DUE TO INFECTION AFTER THREE MONTHS FROM PRIMARY SURGERY. THE SURGEON REVISED THE INSERT.
Patient problems: Unspecified Infection
MAUDE report 7888903 ↗
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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