QUANTUM M05 01001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03701337601126), received between Sep 19, 2025 and Sep 19, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Break; Break

  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: TALAR CHAMFER RESECTION GUIDES (INTRA-OPERATIVELY) IT WAS REPORTED BY THE SALES REP, DURING THE PLACEMENT OF THE TALAR CHAMFER RESECTION GUIDES INTO HARD BONE, DR. (B)(6) APPLIED PRESSURE TO GET THE INSTRUMENT IN THE DESIRED ORIENTATION, LEVERING THE INSTRUMENT TO ADJUST THE PLANE. DURING THE PLACEMENT OF THE INSTRUMENT ONE OF THE TROCAR T

  Patient problems: Insufficient Information

  MAUDE report 23096472 ↗