QUANTUM M50 ST240Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03701337601393), received between Sep 19, 2025 and Sep 19, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2025Migration; Migration

  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: INITIAL SURGERY DATE: (B)(6) 2022. SITUATION: TIBIAL IMPLANT MIGRATION AND POSTOPERATIVE MALLEOLAR FRACTURE THE PATIENT UNDERWENT REVISION SURGERY FOLLOWING AN X-RAY EXAMINATION SHOWING A PERIPROTEAL MALLEOLAR FRACTURE AND VARUS MIGRATION AND ANTERIOR SLOPE OF THE QUANTUM TIBIAL IMPLANT. THE REVISION SURGERY TOOK PLACE ON MONDAY (B)(6) 2023. THE TIBIAL IMPLANT AND POLYETHYLENE INSERT WERE EXPLANTED, A 2.0MM TIBIAL CUT WAS MADE AND A NEW TIBIAL IMPLANT AND INSERT WERE RE-IMPLANTED. TH

  Patient problems: Bone Fracture(s)

  MAUDE report 23093730 ↗
• InjurySep 19, 2025Migration; Migration

  THE QUANTUM® TOTAL ANKLE PROSTHESIS IS INDICATED AS A TOTAL ANKLE REPLACEMENT IN PRIMARY OR REVISION SURGERY FOR PATIENTS WITH ANKLE JOINTS DAMAGED BY SEVERE RHEUMATOID, POST-TRAUMATIC, OR DEGENERATIVE ARTHRITIS. THE QUANTUM® TOTAL ANKLE PROSTHESIS IS A FIXED-BEARING, SEMI-CONSTRAINT ANKLE PROTHESIS WITH 2 COMPONENTS 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: PATIENT MALE 46 YEARS OLD OPERATED WITH A QUANTUM PROSTHESIS ON (B)(6) 2022, (B)(6) CLINIC - (B)(6) DOCTOR (B)(6). AT 10 MONTHS THE PATIENT IS IN PAIN. UNDER ANTI-INFLAMMATORY TREATMENT. THE RADIOGRAPH SHOWS A LUCENCY PROXIMAL TO THE BASE OF THE TIBIAL IMPLANT. WE ALSO NOTICE THE FORMATION OF ANTERIOR AND POSTERIOR OSTEOPHYTES AS WELL AS THE F

  Patient problems: Implant Pain

  MAUDE report 23093679 ↗