HIP Instruments 01.22.10.0109Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630040738958), received between Apr 20, 2022 and Mar 28, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Disconnect” (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 16, 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.

• MalfunctionMar 28, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  M-VIZION STEM WAS IMPLANTED ON (B)(6) 2025. THE PATIENT NEEDED TO BE REVISED BECAUSE WAS EXPERIENCING PAIN, INSTABILITY AND LEG LENGTH DISCREPANCY, DUE TO A TOO SHORT PROXIMAL BODY IMPLANTED AT THE PRIMARY SURGERY. THE REVISION SURGERY TOOK PLACE 1 MONTH AFTER THE PRIMARY SURGERY AND THE PLAN WAS TO REVISE ONLY THE PROXIMAL BODY (MDR 2025-00242). HOWEVER, THE DISASSEMBLY ROD BENT DURING PROXIMAL STEM EXTRACTION FROM THE DISTAL BODY. DESPITE THE ATTEMPTS, THE PROXIMAL BODY COULD NOT BE REMOVED FROM THE DISTAL STEM, THEREFORE THE SURGEON DECIDED TO REMOVE THE ENTIRE STEM (PROXIMAL + DISTAL). SURGERY WAS EXTENDED BY ABOUT 15 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21717552 ↗
• MalfunctionApr 20, 2022Failure to Disconnect

  DURING THE REVISION HIP SURGERY, DURING THE IMPLANT REMOVAL ATTEMPT, THE SURGEON WAS NOT ABLE TO THREAD THE PROXIMAL BODY HANDLE (01.22.10.0151 - 2055070) ONTO THE IMPLANTED PROXIMAL BODY. HE THEN SWITCHED TO THE SECOND HANDLE IN THE TRAY (01.22.10.0151 - 2053402) AND SUCCESSFULLY THREADED THE HANDLE ONTO THE PROXIMAL BODY. THE DISASSEMBLY TOOL (01.22.10.0110 - 1853910) WOULD THEN NOT THREAD INTO THE HANDLE. SINCE THE DISASSEMBLY TOOL WAS NOT USABLE, THE SURGEON APPLIED VICE GRIPS TO THE HANDLE (2053402) THAT WAS ATTACHED TO THE PROXIMAL BODY AND ATTEMPTED TO KNOCK THE BODY LOOSE FROM THE STEM. AFTER FAILING TO DISENGAGE, THE SURGEON SWITCHED TO THE FIRST HANDLE (2055070) AND WAS ABLE TO THREAD IT INTO THE PROXIMAL BODY. AT THIS POINT, THE DISASSEMBLY TOOL WAS THREADED INTO THE HANDLE AND USED AS DESIGNED WITH THE DISASSEMBLY ROD TO ATTEMPT TO DISENGAGE THE BODY FROM THE STEM, WHICH FAILED. THE DISASSEMBLY ROD FAILED TO DISENGAGE THE MORSE TAPER BETWEEN THE DISTAL STEM AND THE BODY. THE SURGEON HAD TO DO AN EXTENDED TROCHANTERIC OSTEOTOMY IN ORDER TO REMOVE THE M-VISION IMPLANTS FROM THE FEMUR. THERE WAS A 1-HOUR DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. A CONSIGNMENT SET W

  Patient problems: Laceration(s)

  MAUDE report 14159205 ↗