OSCAR 3 1 (REF OHP2080SU)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18056099649766), received between Apr 28, 2021 and Apr 28, 2021 — classified as 1 malfunction.

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 16, 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.

• MalfunctionApr 28, 2021Break; Break

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - PRODUCT CODE: OHS2080SU AND OHP2080SU (MFR REPORTS 9680825-2021-00033 AND 9680825-2021-00034 RESPECTIVELY) - BATCH NUMBERS: B1455982 AND B1472893 - QUANTITY: 1 EACH - DATE OF INITIAL SURGERY: (B)(6) 2021 - BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR - SURGERY DESCRIPTION: ARTHROPLASTY REVISION - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM - EVENT DESCRIPTION: "WHEN BEING USED INTRAOPERATIVELY THE TIPS OF THE PROBES BROKE OFF THE PROBES. THE TIPS RESIDE IN THE PATIENT'S FEMUR. THE SURGEON WAS UNABLE TO REMOVE THE BROKEN TIPS". THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (UN-RETRIEVED DEVICE FRAGMENTS) - THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE - AN ADDITIONAL SURGERY WAS NOT REQUIRED - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED - COPY OF OPERATIVE REPORTS ARE AVAILABLE (NOT RECEIVED BY ORTHOFIX (B)(4)) - PRODUCT IS NOT AVAILABLE FOR RETURN ON APRIL 14, 2021, ORTHOFIX (B)(4) RECEIVED THE FOLLOWING DETAILS FROM THE SALES REPRESENTATIVE: "THE HOSPITAL DISPOSED O

  Patient problems: Foreign Body In Patient

  MAUDE report 11736293 ↗