CHIMAERA Hip Fracture System 1 (REF 99-T93695)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 18054242514923), received between Oct 15, 2018 and Sep 1, 2026 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionSep 1, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50550450 ↗
• MalfunctionApr 24, 2019Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE HOSPITAL INVOLVED AND THE SALES MANAGER INDICATES: HOSPITAL NAME: (B)(6) UNIVERSITARIA. SURGEON NAME: (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2019. BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT FEMUR. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: 89 YEARS, FEMALE, 70 KG, 167 CM, WITH COGNITIVE IMPAIRMENT, BALANCE AND MOVEMENT DISORDER. PROBLEM OBSERVED DURING TREATMENT. EVENT DESCRIPTION: "A CHIMAERA LAG SCREW FIXED DID NOT MATE THE NAIL. THE INTERVENTION WAS CONCLUDED USING A CHIMAERA LAG SCREW SLIDING. THERE WAS 15 MINUTES DELAY OF THE SURGERY TIME." THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL INTERVENTION WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. ON APRIL 17, 2019, ORTHOFIX SRL RECEIVED COPIES OF THE X-RAY IMAGES. MANUFACTURER REFERENCE NUMBER: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8544795 ↗
• InjuryOct 15, 2018Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE SALES MANAGER INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: DR (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2018. BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: FEMALE. PROBLEM OBSERVED DURING TREATMENT; EVENT DESCRIPTION: FOLLOWING A FALL ON (B)(6), PATIENT RETURNED TO THE HOSPITAL FOR A CHECK. FROM THE RADIOGRAPHIC CONTROL (POST FALL) THE NAIL POSITION DID NOT CHANGE, BUT AFTER 10 DAYS FROM FALL IT WAS EVIDENCED THE SLIPPAGE OF THE CEPHALIC SCREW. THE SCREW "DISCONNECTED" FROM THE NAIL. THE PATIENT WILL HAVE TO UNDERGO AN ADDITIONAL SURGERY TO REMOVE THE NAIL. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT. THE SURGERY WAS COMPLETED WITH THE DEVICE. FOLLOWING THE DEVICE FAILURE IT WAS NECESSARY AN ADDITIONAL SURGERY: REMOVAL OF THE NAIL PERFORMED ON (B)(6) 2018. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE AVAILABLE: ORTHOFIX SRL RECEIVED X-RAYS TAKEN BEFORE SURGERY, AFTER SURGERY, AFTER 10 DAYS FROM PATIENT FALL. PATIENT CURRENT HEALTH CONDITION: N/A.

  Patient problems: No Code Available

  MAUDE report 7964291 ↗