Hip Instruments 01.18.10.102Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040751780), received between Apr 5, 2019 and Feb 12, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2021Fracture; Appropriate Device Problem Term/Code Not Available

  THE SURGEON DISCOVERED THE FRACTURE AROUND THE FEMORAL STEM BY CT-IMAGE DURING FEMORAL BONE RASPING. THE SURGEON FIXED THE FRACTURE WITH THE NESPLON TAPE, AND INSERTED THE AMISTEM-P SHORT NECK STD SIZE 4. DAA SURGERY. AMIS LEG POSITIONER WAS USED. LOT NUMBER OF THE INSTRUMENT IS UNAVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 11322060 ↗
• InjuryAug 28, 2019Fracture

  AFTER FEMORAL RASPING, THE SURGEON TRIED TO REPOSITION AND FELT AN ABNORMAL FEELING. CHECKING THE CT IMAGE HAS BEEN DISCOVERED THE TRANSVERSE FRACTURE ABOUT 10MM FURTHER THAN THE DISTAL RASPING POINT. THE SURGEON FIXED THE FRACTURE AND CABLE. DUE TO THIS EVENT, THE SURGERY WAS PROLONGED ABOUT 2 HOURS. TOTAL SURGERY TIME WAS ABOUT 4 HOURS. THE RASP DID NOT SHOW ANY DEFORMATIONS OR SCRATCHES.

  Patient problems: Bone Fracture(s)

  MAUDE report 8939223 ↗
• InjuryApr 5, 2019Break; Mechanical Problem

  DURING SURGERY THE FEMORAL BONE BROKE WHEN THE SURGEON TRIED TO ENGAGE THE HANDLE WITH THE RASP. FEMORAL BONE WAS FIXED WITH THE WIRE. THE SURGEON COMMENTED THAT IT WAS HARD TO ENGAGE THE HANDLE WITH THE RASP.

  Patient problems: Bone Fracture(s)

  MAUDE report 8486483 ↗