MOTO Partial Knee System - Medial 02.18.TF4.RMRecalls & reported problems
Medacta International SA · Tibial Tray Fix 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030896767), received between Nov 15, 2022 and May 12, 2023 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth2
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 12, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY AT ABOUT 1 YEAR AND 7 MONTHS POST PRIMARY FOR CEMENTED TIBIAL TRAY LOOSENING. ALL COMPONENTS REVISED AND GMK SPHERE WAS IMPLANTED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 16917557 ↗InjuryJan 11, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
AT ABOUT 2 YEARS AND 1 MONTH POST PRIMARY, REVISION SURGERY FOR MOTO TIBIA AND FEMUR (MEDIAL) IMPLANTS LOOSENING. GMK SPHERE IMPLANTED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16139959 ↗MalfunctionNov 15, 2022No Apparent Adverse Event; No Apparent Adverse Event
DURING IMPACTING OF THE FINAL IMPLANTS, THE TIBIA WOULD NOT STAY SEATED AND KEPT LIFTING UP. THE TIBIA WAS REMOVED, AND ALL THE CEMENT AS WELL. THE SURGEON REATTEMPT THE KEEL PREPARATION AND IMPACTED THE TIBIA AGAIN WITH A SECOND FRESH MIX OF CEMENT BUT STILL THE TIBIA WOULD NOT SEAT FULLY AND WAS LIFTING. FOR A SECOND TIME, HE HAD TO TAKE OUT THE TIBIA AND REMOVE THE CEMENT FROM IT AND ATTEMPTED A THIRD PREPARATION OF THE KEEL, BUT THIS TIME USING JUST THE KEEL GUIDE AND A NARROW OSTEOTOME. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15796859 ↗
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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