Knee Instruments 02.07.10.8651Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07630345713148), received between Aug 2, 2023 and Mar 31, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Fracture

  THE ANTIROTATIONAL INSERT OF THE TRIAL OFFSET 3MM BROKE AND REMAINED ATTACHED THE TIBIAL PUNCHER, WHILE THE BODY OF THE TRIAL OFFSET REMAINED STUCK IN THE TIBIAL CANAL. ABOUT 45 MINUTES WERE REQUIRED TO REMOVE THE BROKEN PART AND THE SURGEON HAD TO REMOVE PART OF THE TIBIAL BONE TO BE ABLE TO GRAB THE OFFSET. BROKEN PART RETRIEVED AND SURGERY COMPLETED SUCCESSFULLY. BONE QUALITY NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24738824 ↗
• MalfunctionJan 29, 2026Fracture

  THE ANTI-ROTATIONAL INSERT OF THE TRIAL OFFSET 3MM BROKE DURING THE REMOVAL OF THE TRIAL ASSEMBLY. CLAMP USED TO REMOVE THE PART (5 MINUTES DELAY TO RECOVER THE PIECE). SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208585 ↗
• MalfunctionJul 4, 2025Fracture; Fracture

  THE ANTIROTATIONAL INSERT OF THE TRIAL OFFSET 3MM BROKE. BROKEN PART RETRIEVED AND SURGERY COMPLETED SUCCESSFULLY. 1 HOUR DELAY OCCURRED TO REMOVE THE BROKEN PART. THE SURGEON HAD TO CUT THE DIAPHYSIS TO BE ABLE TO GRAB THE OFFSET AND PULL OUT THE OFFSET AND STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22403097 ↗
• MalfunctionFeb 20, 2025Fracture; Fracture

  THE ANTIROTATIONAL INSERT OF THE TRIAL OFFSET 3MM BROKE AND REMAINED INSIDE THE TRIAL FEMUR AND STEM. THE OPERATION WAS EXTENDED BY AROUND 30 MINUTES AND THE PATIENT HAD TO REMAIN UNDER ANESTHESIA LONGER. IN ADDITION, BONE HAD TO BE REMOVED FROM THE ANTERIOR FEMORAL BONE ABOVE THE OFFSET CONNECTOR IN ORDER TO BE ABLE TO GRASP THE SHAFT WITH FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21420549 ↗
• MalfunctionNov 8, 2024Fracture; Fracture

  THE ANTIROTATIONAL INSERT OF THE TRIAL OFFSET 3MM BROKE AND REMAINED INSIDE THE TRIAL STEM. THE SURGEON DRILLED HOLES IN THE TRIAL OFFSET IN ORDER TO HOOK IT AND PULL IT OUT. SURGERY WAS COMPLETED WITH 1 HOUR OF DELAY DUE TO THE ISSUE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20639490 ↗
• MalfunctionMay 6, 2024Fracture; Fracture

  THE ANTI-ROTATIONAL INSERT OF THE TRIAL OFFSET BROKE. THE OFFSET TRIAL AND THE STEM WERE BLOCKED IN THE INTRAMEDULLARY CANAL. THE BROKEN PART WAS REMOVED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248897 ↗
• InjuryDec 4, 2023Fracture; Fracture

  THE ANTI-ROTATIONAL INSERT OF THE TRIAL OFFSET 3MM BROKE DURING THE REMOVAL OF THE TRIAL ASSEMBLY. TO REMOVE THE TRIAL STEM FROM THE INTRAMEDULLARY CANAL, THE SURGEON TRIED TO ENGAGE IT WITH A SECOND TRIAL OFFSET (5 MM) BUT IT BROKE AS WELL. THE SURGEON HAD TO OPEN THE TIBIAL BONE UP TO THE APEX AND THEN PERFORM A TIBIAL CERCLAGE. THERE WAS 1 HOUR AND A HALF OF DELAY IN THE SURGERY DUE TO THIS EVENT. TOTAL SURGERY TIME: ABOUT 3 HOURS.

  Patient problems: Bone Fracture(s)

  MAUDE report 18256291 ↗
• MalfunctionNov 21, 2023Fracture; Fracture

  ON REMOVAL OF THE TRIAL ASSEMBLY COMPONENTS, FROM THE TIBIA BONE, THE ANTI-ROTATIONAL INSERT OF THE TRIAL OFFSET CAME OUT. THE TRIAL STEM REMAINED IN THE TIBIAL. IT WAS REMOVED EASILY WITH A KOCHER. NO DELAY IN THE SURGERY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18184208 ↗
• MalfunctionAug 2, 2023Fracture; Fracture

  THE TRIAL OFFSET 3MM DETACHED FROM THE TRIAL TIBIAL BASEPLATE DURING SURGERY. THE THREADS INSIDE THE TRIAL OFFSET 3MM CAME OUT. SINCE NO THREADED PART OF THE TRIAL OFFSET REMAINED INSIDE, 40 MINUTES WERE NEEDED TO REMOVE THE TRIAL OFFSET AND THE EXTENSION STEM FROM THE TIBIAL CANAL (TOTAL SURGERY TIME OF 2 ½ HOURS). SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17441936 ↗