Knee Instruments 02.12.10.0008Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630971201996), received between Dec 4, 2020 and Dec 9, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Crack” (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 18, 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.

• InjuryDec 9, 2020Fitting Problem

  DURING THE PRIMARY KNEE SURGERY, WHILE THE SURGEON WAS TRIALING THE FEMUR, TIBIA AND INSERT, HE OBSERVED THAT THE TRIALS WERE A TIGHT FIT. THE SURGEON KEPT PUSHING THE TRIAL TIBIA WITH THE INSERT ON IT, AND ENDED UP CRACKING THE PATIENT'S FEMUR MEDIALLY. IN ORDER TO COMPLETE THE CASE, THE SURGEON HAD TO USE A SCREW TO SECURE THE FEMUR. THERE WAS A 15 MINUTE DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. A CONSIGNMENT SET WAS UTILIZED.

  Patient problems: Bone Fracture(s)

  MAUDE report 10974216 ↗
• InjuryDec 4, 2020Crack

  DURING THE PRIMARY KNEE SURGERY, WHILE THE SURGEON WAS TRIALING THE FEMUR, TIBIA AND INSERT, HE OBSERVED THAT THE TRIALS WERE A TIGHT FIT. THE SURGEON KEPT PUSHING THE TRIAL TIBIA WITH THE INSERT ON IT, AND ENDED UP CRACKING THE PATIENT'S FEMUR MEDIALLY. IN ORDER TO COMPLETE THE CASE, THE SURGEON HAD TO USE A SCREW TO SECURE THE FEMUR. THERE WAS A 15-MINUTE DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. A CONSIGNMENT SET WAS UTILIZED.

  Patient problems: Bone Fracture(s)

  MAUDE report 10949698 ↗