Knee Instruments 02.07.10.8652Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07630345713155), received between Sep 22, 2023 and Jul 17, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2025Fracture; Fracture

  DURING THE PRIMARY KNEE SURGERY AND WHILE THE SURGEON WAS DISENGAGING THE TIBIAL FIN PUNCH, THE 5MM TRIAL OFFSET WITH LOCKING SYSTEM BROKE. ALL BROKEN FRAGMENTS WERE RECOVERED AND THERE WAS NO DELAY IN THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529148 ↗
• MalfunctionMar 19, 2025Fracture; Fracture

  DURING THE COMPETITOR REVISION KNEE SURGERY, THE 5MM TRIAL OFFSET THREADED PIECE BROKE OUT OF CHASSIS. THE KEEL CAME OUT WITH THREADS ENGAGED INTO SMALL PIECE THAT CAME OUT OF OFFSET TRIAL, AND THE OFFSET TRIAL AND STEM WERE THEN STUCK IN TIBIAL CANAL. THE REP TRIED FOR 15-20 MIN TO FIND INSTRUMENTATION TO GRAB ONTO OFFSET TRIAL AND REMOVE FROM CANAL. THERE WAS A 20-MINUTE DELAY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642256 ↗
• MalfunctionNov 7, 2024Fracture; Fracture

  TO PREPARE THE TIBIA, THE PREVIOUSLY DETERMINED STEM WAS CONNECTED TO THE KEEL CHISEL WITH THE EQUALLY DETERMINED OFFSET AND IMPACTED USING THE SLIDING HAMMER. THE SLIDE HAMMER WAS ALSO USED FOR REMOVAL. AFTER TWO HITS, THE KEEL CHISEL DETACHED FROM THE OFFSET ADAPTER, BUT THE THREAD IN THE OFFSET ADAPTER CAME LOOSE SO THAT THE OFFSET ADAPTER WITH STEM REMAINED IN THE BONE. VARIOUS EXTRACTION INSTRUMENTS FROM THE CLINIC WERE USED TO REMOVE THE TRIAL IMPLANT, UNFORTUNATELY WITH NO SUCCESS, SO THE ENTIRE BONE AROUND THE OFFSET CONNECTOR HAD TO BE CAREFULLY REMOVED WITH A CHISEL TO PICK IT UP.

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

  MAUDE report 20630405 ↗
• MalfunctionAug 28, 2024Fracture; Fracture

  THE ANTI-ROTATIONAL INSERT OF TRIAL OFFSET BROKE OFF AND BECAME STUCK IN THE PATIENT'S TIBIA. THE SURGERY AND ANESTHESIA WERE PROLONGED BY 30 MINUTES, AND EVENTUALLY THE PIECE WAS REMOVED. THE SURGERY WAS COMPLETED WITH NO FURTHER NEED FOR THE TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085912 ↗
• MalfunctionJun 12, 2024Fracture; Fracture

  THE ANTI-ROTATIONAL INSERT OF THE TRIAL OFFSET BROKE AND WAS STUCK IN THE PATIENT'S TIBIA, WAS REMOVED, USED A BACK-UP TO COMPLETE THE SURGERY.

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

  MAUDE report 19518513 ↗
• MalfunctionMay 28, 2024Fracture; Fracture

  THE ANTI-ROTATIONAL INSERT OF THE TRIAL OFFSET BROKE AND WAS STUCK IN THE PATIENT'S TIBIA, WAS REMOVED, USED A BACK-UP BUT THE SAME ISSUE HAPPENED. HOWEVER, IT WAS POSSIBLE TO TEMPORARILY REPAIR THE SECOND OFFSET AND TO COMPLETE THE SURGERY SUCCESSFULLY.

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

  MAUDE report 19403571 ↗
• MalfunctionFeb 9, 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 DESPITE 30 MINUTEDELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18674302 ↗
• MalfunctionJan 11, 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 18491228 ↗
• MalfunctionNov 24, 2023Fracture; Fracture

  ON REMOVAL OF THE TRIAL ASSEMBLY, THE ANTI-ROTATIONAL INSERT OF THE TRIAL OFFSET CAME OUT. AS A RESULT, THE OFFET TRIAL AND THE STEM WERE BLOCKED IN THE INTRAMEDULLARY CANAL. THERE WERE 20 MINUTES OF DELAY IN THE SURGERY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18204585 ↗
• MalfunctionNov 22, 2023Fracture; Fracture

  ON REMOVAL OF THE TRIAL ASSEMBLY, THE ANTI-ROTATIONAL INSERT OF THE TRIAL OFFSET CAME OUT. THE TRIAL STEM AND TRIAL OFFSET REMAINED THE TIBIAL BONE. THEY WERE REMOVED WITH SOME PLIERS. THERE WERE 20 MINUTES OF DELAY IN THE SURGERY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18191306 ↗
• MalfunctionOct 26, 2023Fracture; Fracture

  MEDTRONIC LEGAL RECEIVED INFORMATION FROM THE ATTORNEY OF THE FAMILY ON OCT 04, 2023, MEDTRONIC RECEIVED NOTICE OF A DEVICE/PRODUCT LEGAL HOLD NOTIFICATION. THE REPORTER ALLEGES THAT THE USE OF ONE OR MORE MEDTRONIC MINI MED 600 SERIES INSULIN PUMPS WITH A DAMAGED, MISSING, OR BROKEN RETAINER RING CAUSED THE CLAIMANT TO SUFFER PERSONAL INJURIES. THE ALLEGATION DID NOT SPECIFY THE PUMP IDENTIFIER (SERIAL NUMBER) AND THEREFORE ALL 600 SERIES INSULIN PUMPS IN POSSESSION OF THE CLAIMANT, INCLUDING THIS PUMP, ARE CONSIDERED POTENTIALLY WITHIN THE SCOPE OF THE REPORT PENDING CONFIRMATION OF THE AFFECTED SERIAL NUMBER(S). WHEN AND IF THE AFFECTED SERIAL NUMBER IS IDENTIFIED, ALL RELATED REPORTS WILL BE UPDATED ACCORDINGLY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE USING ONE OF THE PUMPS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

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

  MAUDE report 18011677 ↗
• MalfunctionOct 23, 2023Break; Fracture; Break; Fracture

  DURING A KNEE REVISION SURGERY AND IMPLANTATION OF GMK HINGE SYSTEM, WITH OSTEOSYNTHESIS OF THE TIBIA,THE ANTIROTATIONAL INSERT OF THE TRIAL OFFSET 5MM DISCONNECTED. THE SURGERY WAS ANYWAY COMPLETED SUCCESSFULLY WITH A TOTAL TIME OF 3H AND A DELAY OF 20MIN. IT HAS BEEN REPORTED THAT THE TIBIAL BONE OF THE PATIENT WAS ALREADY FRACTURED BEFORE THE SURGERY AND THIS FRACTURE FACILITATED THE REMOVAL OF THE PIECE.

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

  MAUDE report 17982917 ↗
• MalfunctionSep 22, 2023Break; Fracture; Break; Fracture

  DURING A REVISION SURGERY, A BROKEN PART OF THE TRIAL OFFSET WITH LOCKING SYSTEM REMAINED BLOCKED IN THE PUNCHER DURING THE SURGERY. THE BROKEN PART IS A METAL CROWN OF THE OFFSET TRIAL. THE ISSUE CAUSED 30-45 MIN OF DELAY IN THE SURGERY.

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

  MAUDE report 17798550 ↗