PHYSICA Instrument Set Fem. Positioner Inserter/ExtractorRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390097956), received between Feb 13, 2025 and Feb 13, 2025 — 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 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.

• MalfunctionFeb 13, 2025Break; Break

  DURING A KNEE SURGERY PERFORMED ON (B)(6) 2025, THE SCREW FROM THE FEMORAL POSITIONER FELL OUT DURING IMPLANTATION OF FEMUR. THE INSTRUMENT INVOLVED IN THE EVENT IS THE FOLLOWING: PHYSICA - FEMORAL POSITIONER (PART CODE 9065.88.120, LOT NUMBER 17AG083). THE SCREW WAS NOTICED ON THE POST-OP X-RAYS. THEN THE SURGEON DECIDED TO TAKE THE PATIENT BACK TO OR TO RETRIEVE THE SCREW. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1952. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Foreign Body In Patient

  MAUDE report 21374165 ↗