CHIMAERA Hip Fracture System 1 (REF 99-T93785)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 18054242514732), received between Jun 20, 2017 and Nov 20, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (3 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.

• MalfunctionNov 20, 2025Mechanical Problem; Mechanical Problem

  RECEIVED INFORMATION STATING THAT A CHIMAERA LAG SCREW FIXED DID NOT LOCK INTO THE NAIL. A SIMILAR SCREW WITH DIFFERENT LENGTH WAS USED TO COMPLETE SURGERY. AS PER REPORTER SURGICAL PROCEDURE WAS DELAYED BY APPROXIMATELY 50 MINUTES. THE PATIENT IS REPORTED AS BEING IN OBSERVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606405 ↗
• InjuryJul 16, 2020Unintended Ejection; Mechanical Problem; Unintended Ejection; Mechanical Problem

  THE INFORMATION PROVIDED BY THE HOSPITAL INDICATES: HOSPITAL NAME: (B)(6); SURGEON NAME: (B)(6); DATE OF THE INCIDENT: (B)(6), 2020; PATIENT INFORMATION: 80 YEAR-OLD, INITIALS: (B)(6); INCIDENT DESCRIPTION: "AFTER LOCKING OF THE CEPHALIC SCREW ON THE NAIL, IT WAS OBSERVED THE BACKING OUT OF THE CEPHALIC SCREW FROM THE NAIL. THE CEPHALIC SCREW DID NOT LOCK ON THE NAIL". ACTION TAKEN: "THE NAIL AND THE CEPHALIC SCREW WERE REMOVED; ANOTHER INTRAMEDULLARY NAIL WAS USED. THERE WAS A DELAY IN THE SURGICAL TIME". THE DEVICE IS AVAILABLE FOR THE INVESTIGATION. FURTHER INFORMATION RECEIVED FROM THE HOSPITAL THROUGH THE TERRITORY MANAGER: - BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR - SURGERY DESCRIPTION: FRACTURE TREATMENT - PATIENT'S DETAILS: 88 YEAR-OLD, MALE, PREVIOUS HEALTH CONDITION: GOOD GENERAL CONDITION - EVENT DESCRIPTION: DURING THE POSITIONING OF THE CEPHALIC SCREW, THE SCREW DID NOT ENGAGE THE NAIL. SCREW AND NAIL WERE REPLACED WITH ANOTHER IMPLANT. - THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT - THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE - THE SURGERY WAS COMPLETED WITH A GAMMA 3 NAIL FROM ANOTHER COMPANY - THE EVENT LED TO A DELAY IN THE DURATION OF THE S

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10282357 ↗
• InjuryJun 20, 2017Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6); SURGEON NAME: DR. (B)(6); DATE OF SURGERY: 6 WEEKS AGO; BODY PART TO WHICH DEVICE WAS APPLIED: HIP; SURGERY DESCRIPTION: FRACTURE TREATMENT; PATIENT INFORMATION: NO RESPONSE PROVIDED; PROBLEM OBSERVED DURING: NO RESPONSE PROVIDED; TYPE OF PROBLEM: NO RESPONSE PROVIDED. EVENT DESCRIPTION: AFTER HIP FRACTURE AFTER 6 WEEKS, CUT OUT WITH CHIMAERA, IT SEEMS THAT THE LAG SCREW DIDN'T WORK.....NO DYNAMISATION.......I HAVE THE IMPLANT WITH ME AND WILL SEND THE PICTURES WITH, TELL ME IF I CAN SEND YOU THE IMPLANTS. DR (B)(6) HAD TO REMOVE AND CHANGE WITH TOTAL HIP REPLACEMENT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT; THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE; AN ADDITIONAL SURGERY WAS REQUIRED; AVAILABILITY ABOUT COPIES OF THE OPERATIVE REPORTS: NO RESPONSE PROVIDED; COPIES OF THE X-RAYS IMAGES ARE AVAILABLE; INFORMATION ABOUT PATIENT CURRENT HEALTH CONDITION: NO RESPONSE PROVIDED. MANUFACTURER REFERENCE NUMBER: (B)(4).

  Patient problems: No Code Available

  MAUDE report 6653608 ↗