CHIMAERA Hip Fracture System 1 (REF 99-T93125)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18054242514282), received between Jul 20, 2020 and Jul 20, 2020 — classified as 1 injury.

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

• InjuryJul 20, 2020Break; Break

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON'S NAME: UNKNOWN. DATE OF INITIAL SURGERY: (B)(6) 2019. BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT'S INFORMATION: UNKNOWN. PROBLEM OBSERVED DURING: INTO TREATMENT/POSTOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "BY (B)(6) 2019, A SHORT CHIMAERA NAIL WAS IMPLANTED WITH SUCCESS. BY (B)(6) 2020, PATIENT FELL DOWN AGAIN AND NAIL GOT BROKEN." THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED: PERFORMED ON (B)(6) 2020. COPY OF OPERATIVE REPORTS AND X-RAY IMAGES ARE NOT AVAILABLE. PRODUCT IS NOT AVAILABLE FOR RETURN: DEVICE HAS BEEN THROWN AWAY. PATIENT CURRENT HEALTH CONDITION: NAIL HAS BEEN EXTRACTED AND REPLACED BY A PROTHESIS. PATIENT IS OK SO FAR. NOTE: SURGEON THINKS THAT THE FALL DOWN CAN NOT BE THE ONLY REASON FOR NAIL BREAKING. ON 20 JULY 2020, ORTH

  Patient problems: No Code Available

  MAUDE report 10295121 ↗