Knee Instruments 02.07.10.4888Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630971268029), received between Jul 30, 2020 and Jul 30, 2020 — classified as 1 injury.

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

• InjuryJul 30, 2020Appropriate Device Problem Term/Code Not Available

  DURING A REVISION SURGERY OF A COMPETITOR KNEE TO A MEDACTA KNEE, THE SURGEON WAS STARTING TO PREP FOR THE FEMORAL CONE,. WHILE PREPPING FOR THE FEMORAL CONE, THE SURGEON PULLED THE HINGE FEMORAL TRIAL OFF AND OBSERVED HE HAD FRACTURED THE DISTAL FEMORAL CONDYLE. THE SURGEON DECIDED NOT TO REVISE THE PATIENT WITH MEDACTA PRODUCTS AND INSTEAD REVISED WITH COMPETITOR PRODUCTS. IT WAS ALSO OBSERVED THAT THE PATIENT HAD VERY POOR BONE QUALITY. THERE WAS A 1 HOUR AND 45 MINUTE DELAY IN THE CASE AND ADDITIONAL ANESTHESIA WAS NECESSARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE FRACTURE REASON'S IS BONE LOSS AND BONE QUALITY. THE POINT OF FRACTURE IS MEDIAL FEMORAL CONDYLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 10343416 ↗