CHIMAERA Hip Fracture System 1 (REF 99-T93705)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18054242514770), received between Jun 4, 2019 and Jun 4, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2019Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE HOSPITAL INVOLVED AND THE SALES MANAGER INDICATES: HOSPITAL NAME: (B)(6), SURGEON NAME: DR. (B)(6), DATE OF INITIAL SURGERY: (B)(6) 2019, BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR, SURGERY DESCRIPTION: FRACTURE TREATMENT, PATIENT INFORMATION: FEMALE, (B)(6), PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE, TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM, EVENT DESCRIPTION: "DURING THE ENGAGEMENT PHASE OF THE MAIN SLIDING SCREW IT STOPPED WITHOUT ENGAGING PROPERLY AND IT WAS NOT POSSIBLE TO REMOVE IT. THE SAME HAPPENED WITH THE SUPPLEMENTARY LAG SCREW". THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF FRACTURE REDUCTION. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICES. THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE: DELAY IN SURGERY AND CUT OUT. PATIENT'S X-RAY IMAGES ARE AVAILABLE. MANUFACTURER REFERENCE NUMBER: (B)(4).

  Patient problems: No Code Available

  MAUDE report 8666699 ↗