OSCAR 3 1 (REF OS3000)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 18056099649971), received between Mar 31, 2021 and Mar 22, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2026Electrical /Electronic Property Problem

  RECEIVED INFORMATION THAT ALLEGED THE OSCAR 3 GENERATOR MALFUNCTION DURING SURGERY. THE PENETRATION OF THE FEMUR CORTEX OCCURRED. NO OTHER DETAILS WERE PROVIDED.

  Patient problems: Perforation

  MAUDE report 24658303 ↗
• InjuryApr 4, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: DATE OF INITIAL SURGERY: (B)(6) 2022. BODY PART TO WHICH DEVICE WAS APPLIED: FEMORAL CANAL. SURGERY DESCRIPTION: ARTHROPLASTY REVISION. PATIENT'S INFORMATION: 80 YEAR-OLD, MALE, WEIGHT: 89.2 KG; HEIGHT: 163.9 CM; PREVIOUS HEALTH CONDITION: PRIMARY CEMENTED THR. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: THE MACHINE WAS COMPLETELY NOT DELIVERING ANY ENERGY TO MELT THE CEMENT HALF WAY THROUGH THE SURGERY. THE OSCAR WAS IN USE PRIOR TO THAT APPROXIMATELY 30-45 MINUTES, THE TEAM TRIED DIFFERENT HAND PIECES AND CONNECTED TO DIFFERENT TERMINALS. IT STOPPED WORKING IN THE MIDDLE OF THE FEMORAL CANAL WHERE THE CEMENT IS MORE IN QUANTITY BELOW THE OLD STEM LOCATION. THE SURGEON WAS UNABLE TO ADVANCE THE PIERCER PROBE OHP 2080SU 8 MM. THE CEMENT WAS NOT MELTING AT ALL THOUGH IT MADE THE ULTRASONIC SOUND. THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF ACHIEVED CORRECTION THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE A REPLACEMENT DEVICE OF SAME MODEL WAS NOT IMMEDIATELY AVAILABLE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13993215 ↗
• InjuryJun 3, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: DATE OF INITIAL SURGERY: (B)(6) 2021. SURGERY DESCRIPTION: ARTHROPLASTY REVISION. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "WHEN USING OSCAR, THE PIERCER WENT THROUGH THE CEMENT AND GOT STUCK. SURGERY TOOK THREE TIMES LONGER THAN NORMALLY WOULD HAVE. PATIENT ALSO LOST MORE BLOOD THAN EXPECTED". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT; THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE; A REPLACEMENT DEVICE OF SAME MODEL WAS NOT IMMEDIATELY AVAILABLE TO COMPLETE SURGERY (SURGERY COMPLETED WITH OSTEOTOMES); THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: TWO HOURS. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPY OF OPERATIVE REPORTS AND X-RAY IMAGES ARE NOT AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. ON (B)(6) 2021, ORTHOFIX SRL RECEIVED THE FOLLOWING DETAILS FROM THE SALES REPRESENTATIVE: PATIENT INFORMATION (AGE, SEX AND WEIGHT) IS NOT AVAILABLE; THE PATIENT IS CURRENTLY WELL; THE PROBLEM SEEMS TO BE

  Patient problems: Oversedation

  MAUDE report 11928087 ↗
• InjuryMar 31, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - DATE OF INITIAL SURGERY: (B)(6) 2021. - SURGERY DESCRIPTION: ARTHROPLASTY REVISION. - PATIENT'S INFORMATION: 68 YEARS, MALE, IN GOOD HEALTH CONDITION. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: "REPETITION OF AN ERROR MESSAGE "POOR SIGNAL"; DIFFICULTY TO PROGRESS WITH THE CEMENTED PROBES; BROKEN PROBE". THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. - THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: 1 HOUR TOTAL DELAY; WRONG ROAD IN THE FEMUR. - AN ADDITIONAL SURGERY WAS NOT REQUIRED. - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. - COPY OF OPERATIVE REPORTS AND X-RAY IMAGES ARE NOT AVAILABLE. - PRODUCT IS AVAILABLE FOR RETURN. ON MARCH 22, 2021, ORTHOFIX SRL RECEIVED THE FOLLOWING DETAILS FROM THE SALES REPRESENTATIVE: "THE COMPLAINT IS RELATED TO AN OSCAR GENERATOR CODE OS3000, SERIAL NUMBER (B)(6) (MFR REPORT 9680825-2021-00021) AND ONE PIERCER PROBE CODE OHP2062SU BATCH B1387807 (MFR REPORT 9680825-2021-00022). DURING SURGERY, THE PROBE DID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11594066 ↗