CHIMAERA Hip Fracture System 1 (REF 99-T93790)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 18054242514749), received between Nov 30, 2017 and Mar 11, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2026Mechanical Problem

  IT WAS REPORTED THAT A PORTION OF A CHIMAERA SCREW IMPLANTED ON (B)(6) 2025, DISENGAGED DURING TREATMENT. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567807 ↗
• InjuryJan 14, 2021Unintended Movement; Unintended Movement

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) HOSPITAL. SURGEON'S NAME: (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2020. BODY PART TO WHICH DEVICE WAS APPLIED: TROCHANTERIC FRACTURE. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT'S INFORMATION: (B)(6) YEAR-OLD, FEMALE, WEIGHT (B)(6) KG., HEIGHT 1.60 CM, PREVIOUS HEALTH CONDITION: DIABETES, HIGH BLOOD PRESSURE, SMOKING. PROBLEM OBSERVED DURING: INTO TREATMENT/POSTOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "ON THE (B)(6) 2020, A PATIENT WAS OPERATED FOR A TROCHANTERIC FRACTURED, TREATED WITH CHIMAERA TROCHANTERIC NAIL. ON DECEMBER 16TH, IT WAS REPORTED TO OUR SALES REPRESENTATIVE THAT A COMPLICATION AROSE AS THE BARREL OF THE SLIDING LAG SCREW APPEARED TOTALLY APART LYING INTO THE SOFT TISSUE OF THE FEMUR." THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF ACHIEVED CORRECTION, LOSS OF STABILITY. 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 REQUIRED: A REVISION SURGERY IS SCHEDULED TO TAKE PLACE IN THE FOLLOWING DAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11168821 ↗
• MalfunctionMar 9, 2020Break; Break

  THE INFORMATION PROVIDED BY THE HOSPITAL INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2020 . BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: (B)(6) YEAR-OLD, FEMALE, WEIGHT (B)(6) KG., HEIGHT 140 CM; PREVIOUS HEALTH CONDITION: GOOD CONDITIONS. INDEPENDENT. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "WHEN INSERTING THE CEPHALIC SCREW IT WAS NOT POSSIBLE TO SCREW IT AS IT DID NOT LOCK ON NAIL. THE SCREW WAS EXTRACTED AND IT WAS OBSERVED THE BREAKAGE OF 3 OUT OF 6 OF THE TEETH. TWO OF THEM HAVE NOT BEEN RETRIEVED." THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY. THE EVENT LED TO AN INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE OF 5 MINUTES. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPY OF OPERATIVE REPORTS IS AVAILABLE. COPY OF X-RAY IMAGES IS AVAILABLE. PATIENT'S

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9805962 ↗
• InjuryDec 10, 2018Break; Break

  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: N/A; SURGERY DESCRIPTION: FRACTURE TREATMENT; PATIENT INFORMATION: N/A; PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE; EVENT DESCRIPTION: FEMORAL NECK WAS NOT PROPERLY REDUCED AND FIXED IN A NECK ANGLE GREATER THAN WHAT IS RECOMMENDED. THE MAIN LAG SCREW BROKE AS PER ATTACHED PICTURES. NAIL WAS EXTRACTED, AND CHIMAERA WAS USED FOR RE FIXATION. THE INITIAL PROCEDURE WAS DONE AT (B)(6) HOSPITAL. THE 2ND PROCEDURE WAS DONE AT (B)(6) ON (B)(6) 2018 THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF FRACTURE REDUCTION AND LOSS OF ACHIEVED CORRECTION. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. AN ADDITIONAL SURGERY WAS REQUIRED FOLLOWING DEVICE FAILURE: PERFORMED ON (B)(6) 2018. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE COPIES OF THE X-RAY IMAGES ARE AVAILABLE. PATIENT CURRENT HEALTH CONDITION: N/A. ON (B)(6) 2018, ORTHOFIX (B)(4) RECEIVED COPY OF X-RAY IMAGES AND THE FOLLOWING FURTHER INFORMATION: "PLEASE FIND ATTACHED FORM AND

  Patient problems: No Code Available

  MAUDE report 8145793 ↗
• InjuryNov 30, 2017Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE SALES MANAGER INDICATES: HOSPITAL NAME: (B)(6); SURGEON NAME: (B)(6); DATE OF INITIAL SURGERY: (B)(6) 2017; BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR; SURGERY DESCRIPTION: FRACTURE TREATMENT; PATIENT INFORMATION: (B)(6), FEMALE; PROBLEM OBSERVED DURING TREATMENT; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: "DURING A CHIMAERA IMPLANT (CODE OF THE NAIL WAS 99-T93125), A LAG SCREW (DEVICE CODE 99-T93790) WAS INSERTED. DURING THE COMPRESSION PHASE, THE SCREW CAME OUT OF THE NAIL. FROM THE INFORMATION AVAILABLE, IT SEEMS TO ME THAT THE WINGS OF THE LAG SCREW DID NOT HOOK-UP TO THE NAIL. ONCE THE SCREW WAS REMOVED, THE SURGEON WAS NOT ABLE TO RELEASE THE SCREW FROM THE SCREWDRIVER THEREFORE THE PROPER INSTRUMENTATION TO RE-IMPLANT THE CEPHALIC SCREW WAS NOT MORE AVAILABLE. TO CONCLUDE THE SURGERY, THE SURGEON DECIDED TO USE THE RETENTION ROD (DEVICE CODE 193282). IN THIS CONDITION HE WAS NOT ABLE TO DO A SUFFICIENT FORCE TO COMPLETE THE SCREW INSERTION. THESE MANEUVERS CAUSED THE BREAKAGE OF THE RETENTION ROD. THE INTERVENTION ENDED WITH THE LAG SCREW IMPLANTED (BUT A PORTION OF THE RETENTION ROD IS STUCK IN IT) ". THE COMPLAINT REPOR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7070035 ↗