PHYSICA PS Tibial Liner (REF 6535.50.810)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390096164), received between Jan 30, 2026 and Jan 30, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryJan 30, 2026Unstable; Detachment of Device or Device Component

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO KNEE INSTABILITY AND LOOSENING OF LINER. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL IMPLANT. DURING REVISION THE PRE-EXISTING PHYSICA PS TIBIAL LINER #8 H10 (PART NUMBER 6535.50.810) WAS REMOVED AND A THICKED LINER PHYSICA PS TIBIAL LINER #8 H16 (PART NUMBER 6535.50.816) WAS IMPLANTED. REVISION WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1970. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 24219762 ↗