ORTHOLOCK 6007-003-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540442895), received between Feb 10, 2023 and Sep 24, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Incorrect Measurement

  It was reported that during femoral impaction, the Ortholock became loose, resulting in loss of navigation functionality. Consequently, the procedure was completed using conventional manual instrumentation. Due to reduced navigational accuracy following device instability, bone cement was utilized to complete the procedure. No adverse patient outcome was reported.

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

  MAUDE report 50882151 ↗
• MalfunctionFeb 12, 2026Incorrect Measurement

  DURING A PROCEDURE AT THE USER FACILITY, THE HIP NAVI (DURING CUP PLACEMENT), THE ORTHOLOCK LOOSENED, CAUSING A SIGNIFICANT DROP IN ACCURACY, RENDERING THE NAVI UNUSABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24323474 ↗
• MalfunctionFeb 12, 2026Incorrect Measurement

  DURING A PROCEDURE AT THE USER FACILITY, THE HIP NAVI (DURING CUP PLACEMENT), THE ORTHOLOCK LOOSENED, CAUSING A SIGNIFICANT DROP IN ACCURACY, RENDERING THE NAVI UNUSABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24323473 ↗
• MalfunctionFeb 10, 2023Incorrect Measurement; Improper or Incorrect Procedure or Method; Incorrect Measurement; Improper or Incorrect Procedure or Method

  PER THE CUSTOMER, LICENSING FOR THE AUTOMATED FUNCTIONALITY PORTION OF THE Q GUIDANCE SYSTEM WAS NOT LOADED CORRECTLY. THE CUSTOMER INSTEAD USED THE NON-AUTOMATED SOFTWARE PACKAGE AVAILABLE WITH THE Q GUIDANCE SYSTEM. WHILE PLACING A HIP PIN, MOVEMENT WAS SHOWN ON THE SCREEN WITHOUT MOVING THE DEVICE. TWO OF THE EIGHT SCREWS WERE SHOWN MEDIAL AFTER FOLLOWING THE PLANNED PROJECTION. PER THE CUSTOMER, IT APPEARED THE SCREWS SHIFTED. PER ADDITIONAL CLARIFICATION, THE ORTHOLOCK PIN SYSTEM WAS USED DURING THE PROCEDURE, HOWEVER; ONLY TWO OF THE THREE SCREWS WERE USED TO FIXATE THE ORTHOLOCK ON THE PATIENT'S ANATOMY, WHICH CAN LEAD TO INACCURACY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16356317 ↗