NA 112280Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00848486015923), received between Aug 2, 2019 and Mar 13, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2023Device Slipped; Detachment of Device or Device Component; Device Slipped; Detachment of Device or Device Component

  UPON INSPECTION OF BUMPED ARRAY, THE SURGEON NOTED THE ARRAY ITSELF HAD COME LOOSE FROM THE POST. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16530439 ↗
• MalfunctionFeb 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Failure to Read Input Signal; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Read Input Signal

  TIBIA REGISTRATION COULD NOT BE COMPLETED. THEY FOUND THE BASE OF THE ARRAY WAS MOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16319166 ↗
• MalfunctionAug 2, 2019Output Problem; Non Reproducible Results; Output Problem; Non Reproducible Results

  DURING A MAKO TKA THE SURGEON HAD DIFFICULT MAINTAINING A REGISTRATION ON THE TIBIA AND FEMUR. ON INSPECTION THE ARRAY ITSELF WAS WOBBLY AT THE CENTRE ATTACHMENT. SURGICAL DELAY OF APPROXIMATELY 1 HOUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8858171 ↗