CHIMAERA Hip Fracture System 1 (REF 99-T93710)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18054242514787), received between Jul 9, 2018 and Aug 18, 2025 — classified as 1 injury, 1 malfunction.

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

• MalfunctionAug 18, 2025Break; Break

  RECEIVED INFORMATION STATING THAT A CHIMAERA LAG SCREW SLIDING DID NOT LOCK INTO THE NAIL. A PORTION OF THE SCREW BROKE OFF INSIDE THE PATIENT. AS PER REPORTER DEVICE FRAGMENTS WERE LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22828019 ↗
• InjuryJul 9, 2018Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON'S NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2018. BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR PROXIMAL. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: (B)(6) YEAR-OLD, FEMALE, (B)(6), PREVIOUS HEALTH CONDITION: ASA III. EVENT DESCRIPTION: CUTTING-OUT OF THE CHIMAERA-NAIL 4 WEEKS AFTER OSTEOSYNTHESIS OF A PERTROCHANTERIC FRACTURE: REMOVAL OF THE CHIMAERA-NAIL AND HIP REPLACEMENT WITH A REVISION ENDOPROTHESIS. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS REQUIRED FOLLOWING DEVICE FAILURE: PERFORMED ON (B)(6) 2018. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE AVAILABLE. FURTHER INFORMATION RECEIVED FROM THE DISTRIBUTOR: RECEIVED COPY OF TWO PREOPERATIVE X-RAY IMAGES. RECEIVED COPY OF TWO POSTOPERATIVE X-RAY IMAGES: POSTOPERATIVE, AFTER FAILURE AFTER THE

  Patient problems: No Code Available

  MAUDE report 7669118 ↗