CHIMAERA Hip Fracture System 1 (REF 99-T93595)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18054242515074), received between Jul 9, 2018 and Jul 9, 2018 — 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.

• InjuryJul 9, 2018Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) HOSPITAL (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, WEIGHT (B)(6), HEIGHT 168 CM, 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 ENDOPROSTHESIS. 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:

  Patient problems: No Code Available

  MAUDE report 7669153 ↗