CHIMAERA Hip Fracture SystemRecalls & reported problems across all models

We found 16 models of CHIMAERA Hip Fracture System by Orthofix Srl in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Apr 20, 2017 and Sep 1, 2026 — classified as 20 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (18 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CHIMAERA Hip Fracture System problems

CHIMAERA Hip Fracture System models

16 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CHIMAERA Hip Fracture System 1

  Rod, Fixation, Intramedullary And Accessories
  5 reports
• CHIMAERA Hip Fracture System 1

  Rod, Fixation, Intramedullary And Accessories
  4 reports
• CHIMAERA Hip Fracture System 1

  Rod, Fixation, Intramedullary And Accessories
  3 reports
• CHIMAERA Hip Fracture System 1

  Rod, Fixation, Intramedullary And Accessories
  3 reports
• CHIMAERA Hip Fracture System 1

  Rod, Fixation, Intramedullary And Accessories
  2 reports
• CHIMAERA Hip Fracture System 1

  Rod, Fixation, Intramedullary And Accessories
  2 reports
• CHIMAERA Hip Fracture System 1

  Rod, Fixation, Intramedullary And Accessories
  2 reports
• CHIMAERA Hip Fracture System 1

  Rod, Fixation, Intramedullary And Accessories
  1 report
• CHIMAERA Hip Fracture System 1

  Rod, Fixation, Intramedullary And Accessories
  1 report
• CHIMAERA Hip Fracture System 1

  Rod, Fixation, Intramedullary And Accessories
  1 report
• CHIMAERA Hip Fracture System 1

  Rod, Fixation, Intramedullary And Accessories
  1 report
• CHIMAERA Hip Fracture System 1

  Rod, Fixation, Intramedullary And Accessories
  1 report
• CHIMAERA Hip Fracture System 1

  Rod, Fixation, Intramedullary And Accessories
  1 report
• CHIMAERA Hip Fracture System 1

  Rod, Fixation, Intramedullary And Accessories
  1 report
• CHIMAERA Hip Fracture System 1

  Rod, Fixation, Intramedullary And Accessories
  1 report
• CHIMAERA Hip Fracture System 1

  Rod, Fixation, Intramedullary And Accessories
  1 report

Recent CHIMAERA Hip Fracture System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50550450 ↗
• MalfunctionApr 20, 2026Mechanical Problem

  RECEIVED INFORMATION STATING THAT DURING REMOVAL OF A CHIMAERA IMPLANT, THE NAIL EXTRACTOR GOT CROSS THREADED IN THE LAG SCREW. IT WAS POSSIBLE TO FINALIZE THE SURGERY, WITH A DELAY OF 30 MINUTES. PATIENT/USER NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24930307 ↗
• MalfunctionApr 17, 2026Mechanical Problem

  Received information stating that during removal of a chimaera implant, the nail extractor got cross threaded in the lag screw. It was possible to finalize the surgery, with a delay of 30 minutes.Patient/user not affected.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24909536 ↗
• 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 ↗
• InjuryDec 23, 2025Break; Break

  RECEIVED INFORMATION STATING THAT DURING THE REMOVAL OF A CHIMAERA NAIL, THE NAIL EXTRACTOR BROKE INSIDE THE CEPHALIC SCREW. THIS LED TO AN EXTENSION OF SURGERY TIME OF TWO HOURS.THE PATIENT WAS REPORTED IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23875741 ↗
• 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 ↗
• InjuryAug 27, 2025Mechanical Problem; Mechanical Problem

  RECEIVED INFORMATION STATING THAT AFTER A MONTH FROM APPLICATION, A CHIMAERA LAG SCREW SLIDING BACKED OUT FROM THE NAIL. A REVISION SURGERY WAS NECESSARY TO REPLACE THE IMPLANT. THE PATIENT IS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22901926 ↗
• 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 10, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE IT WAS NOT POSSIBLE TO REMOVE A CEPHALIC SCREW OF A CHIMAERA IMPLANT APPLIED IN (B)(6) 2024. AS PER REPORTER PATIENT WILL UNDERGO A REVISION PROCEDURE TO REMOVE CHIMAERA IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22466277 ↗
• MalfunctionMay 11, 2022Inadequacy of Device Shape and/or Size; Use of Device Problem; Inadequacy of Device Shape and/or Size; Use of Device Problem

  THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATED: PRODUCT CODE: 99-T93130. BATCH NUMBER: B1693150. DATE OF INITIAL SURGERY: (B)(6) 2022. BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: 68 YEARS, MALE, REVISION KNEE REPLACEMENT. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. EVENT DESCRIPTION: PRODUCT WAS MODIFIED BY SURGEON AND TECHNICAL WORKSHOP INTRA OPERATIVELY TO MAKE IT FIT IN THE PATIENT'S FEMUR. THE INCIDENT OCCURRED RIGHT AT THE BEGINNING OF THE PROCEDURE WHEN THE GUIDE WIRE WAS INSERTED AND IT GOT STUCK. UPON FURTHER IMAGING INVESTIGATION IT WAS DISCOVERED THAT THE PATIENT HAS A REVISION KNEE IMPLANT WITH A STEM RUNNING FROM THE DISTAL END TO THE PROXIMAL HALF OF THE FEMUR AS WELL A CEMENT MANTLE. THE WIRE COULDN'T BE ADVANCED ANY FURTHER AND THIS MEANT THAT THE NAIL COULD NOT BE INSERTED AS PER INTENDED APPROACH. THE MAJOR ISSUE WAS THAT OUR IMPLANT WOULD BE TOO LONG AND THAT IT COULD NOT INSERTED TO THE DESIRED DEPTH AS PER SUBSCRIBED USE. ON 27 APRIL 2022, THE DOCTOR INFORMED ME THAT THERE WAS LOSS OF CORRECTION IN THE PATIENT. HOWEVER, HE WILL LEAVE THE NAIL IN AND MONITO

  Patient problems: Arthralgia; Neck Pain

  MAUDE report 14350876 ↗
• InjuryFeb 23, 2021Break; Mechanical Problem; Break; Mechanical Problem

  THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATED: PRODUCT CODE: (B)(4) (SCREW EXTRACTOR SIZE 4-9 MM), BATCH NUMBER: G190645, QUANTITY: 1, DATE OF SURGERY: (B)(6) 2020, BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR, SURGERY DESCRIPTION: FRACTURE TREATMENT, PATIENT'S INFORMATION:NOT APPLICABLE, PROBLEM OBSERVED DURING: ON SCHEDULED DEVICE REMOVAL, TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM, EVENT DESCRIPTION: "CASE WAS FOR CHIMAERA REMOVAL: WE ASSUMED THE THREADING OF THE MAIN CHIMAERA LAG SCREW WAS DAMAGED AS THE NORMAL SCREW DRIVER COULD NOT ENGAGE INTO THE THREAD, THIS PROBABLY OCCURRED WHEN IT WAS INSERTED. THE SURGEON THEN HAD TO REVERT TO THE SCREW EXTRACTOR TOOL (193337) FOR REMOVAL OF THE MAIN LAG SCREW. AS THE EXTRACTION INSTRUMENT HAS A REVERSE THREAD INTERFACE, ENGAGING IT INTO THE LAG SCREW AND THEN ALSO DISENGAGING THE LAG SCREW FROM THE NAIL. THE PROBLEM WE FACE IS THAT ONCE THE SCREW IS REMOVED, THE SCREW CANNOT BE REMOVED FROM THE EXTRACTOR TOOL RESULTING IN A BROKEN TIP WHEN WE DO SO". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (UN-RETRIEVED DEVICE FRAGMENTS - THE PATIENT WAS IN SURGERY FOR ALMOST 3

  Patient problems: Oversedation

  MAUDE report 11364101 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryApr 27, 2020Break; Break

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - PRODUCT CODE: 99-T932340R (CHIMAERA HFS LONG NAIL RIGHT 125 ° L340MM D11MM STERILE) - BATCH NUMBER: B1010983 - QUANTITY: 1 - HOSPITAL NAME: (B)(6). - SURGEON'S NAME: (B)(6). - DATE OF INITIAL SURGERY: (B)(6) 2020 - BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT FEMUR - SURGERY DESCRIPTION: FRACTURE TREATMENT - PATIENT'S INFORMATION: (B)(6). - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE - TYPE OF PROBLEM: OTHER, SEE EVENT DESCRIPTION - EVENT DESCRIPTION: "BREAKAGE OF THE UPPER END OF THE NAIL. NECESSITY OF 2ND OPERATION WITH REDUCTION AND INTRAMEDULLARY NAIL FIXATION". THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF FRACTURE REDUCTION, LOSS OF ACHIEVED CORRECTION) - 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 (PERFORMED ON (B)(6) 2020) - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED (PERFORMED ON (B)(6) 2020) - COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE - COPIES OF THE X-RAY IMAGES ARE AVAILABLE - PRODUCT IS AVAILABLE FOR RETU

  Patient problems: No Code Available

  MAUDE report 10000665 ↗

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