PHYSICA PS Tibial Liner (REF 6535.50.311)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390095822), received between Jul 15, 2025 and Jul 15, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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.

• MalfunctionJul 15, 2025Difficult to Insert; Mechanical Problem; Difficult to Insert; Mechanical Problem

  DURING THE TKA SURGICAL PROCEDURE PERFORMED ON (B)(6) 2025, A TRIAL LINER OF 11 MM WAS INITIALLY SELECTED AND TESTED. BASED ON THE INTRAOPERATIVE ASSESSMENT, THE SURGEON DECIDED TO PROCEED WITH THE DEFINITIVE 11 MM LINER. UPON ATTEMPTING TO INSERT THE DEFINITIVE 11 MM LINER INTO THE TIBIAL TRAY, IT WAS NOT POSSIBLE TO ACHIEVE PROPER SEATING OF THE COMPONENT. THE SURGEON CONDUCTED A VISUAL INSPECTION TO CHECK FOR ANY RESIDUAL CEMENT FRAGMENTS OR OTHER OBSTRUCTIONS ON THE TRAY SURFACE, BUT NONE WERE IDENTIFIED. DESPITE THIS, MULTIPLE ATTEMPTS WERE MADE, ALL OF WHICH WERE UNSUCCESSFUL. FOLLOWING THESE REPEATED ATTEMPTS, THE SURGEON SUSPECTED A POSSIBLE DEFORMATION IN THE POSTERIOR PART OF THE LINER. A NEW DEFINITIVE LINER OF 12 MM WAS THEN OPENED AND INSERTION WAS ATTEMPTED; HOWEVER, THIS LINER ALSO COULD NOT BE INSERTED INTO THE TIBIAL TRAY. THE SURGICAL PROCEDURE WAS CARRIED OUT IN ACCORDANCE WITH THE RECOMMENDED SURGICAL TECHNIQUE FOR THE PHYSICA PS SYSTEM. ULTIMATELY, IN ORDER TO COMPLETE THE SURGERY, THE LINER WAS INSERTED WITH THE APPLICATION OF FORCE. AS A RESULT OF THIS ISSUE, THE OVERALL SURGICAL TIME WAS PROLONGED BY APPROXIMATELY 30 MINUTES. BELOW IS THE SUSPECTED PRODUCT:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506240 ↗