QUANTUM M50 ST151Recalls & reported problems
In2bones · QUANTUM Tibial Implant Long Right Size 5 · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03701337601461), received between Sep 18, 2025 and Sep 18, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2025Material Fragmentation; Material Fragmentation
MEDICAL DEVICE DESCRIPTION: THE QUANTUM® TOTAL ANKLE PROSTHESIS IS A FIXED-BEARING SEMI-CONSTRAINT ANKLE PROTHESIS WITH 2 COMPONENTS EXISTING IN DIFFERENT SIZES AND MODELS AND COMPOSED OF: - A TIBIAL COMPONENT COMPOSED OF A METALLIC (TA6V) TIBIAL TRAY IMPLANT FIXED TO A POLYMER (UHWMPE) INSERT, - A METALLIC (COCR) TALAR IMPLANT REPRODUCING THE TALUS DOME ANATOMY. WHEN ALL COMPONENTS ARE IMPLANTED, WITH THE INSERT RIGIDLY LOCKED TO THE TIBIAL TRAY, THE POLYETHYLENE INSERT ACTS AS A SINGLE BEARING ALONG THE TALAR DOME, ENABLING FLEXION/EXTENSION AND ROTATION MOVEMENT AT THE REPLACED ANKLE JOINT. EACH COMPONENT OF THE QUANTUM® TOTAL ANKLE PROSTHESIS EXISTS IN DIFFERENT SIZES AND MODELS. EVENT DESCRIPTION : SURGICAL INTERVENTION TO INSTALL A QUANTUM TOTAL ANKLE PROSTHESIS WITH PATIENT SPECIFIC CUTTING GUIDES. DUE TO DIFFICULTIES IN HAVING A COMPLETE IMPACTION OF THE TIBIAL IMPLANT (SCOPIC CONTROL), THE IMPLANT WAS REMOVED MANUALLY (WITHOUT USING INSTRUMENT) IN ORDER TO BE REPOSITIONED AFTER ADDITIONAL PREPARATION WITH THE FIXATION CROSS PREPARATION INSTRUMENTS. THE IMPLANT WAS PLACED ON THE INSTRUMENTATION TABLE, AND THEN IT WAS NOTICED THAT PART OF THE ANTEROMEDIAL COATING OF THE IMPL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23084903 ↗
Other Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer devices
- Vantage 350-22-03Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2 recalls2 reports
- Vantage 350-21-04Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2 recalls0 reports
- INFINITY 33630023Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER60 reports
- INFINITY 33600020Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- INFINITY 33650003Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER55 reports
- Vantage 350-22-02Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall5 reports
- INFINITY 33630022Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER54 reports
- Vantage 350-21-02Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall4 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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