PHYSICA PS Right Femoral Comp.Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390095532), received between Aug 22, 2025 and Jul 22, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  REVISION SURGERY OF RIGHT KNEE PROSTHESIS DUE TO SEPTIC MOBILIZATION. REVISION SURGERY DATE IS (B)(6) 2026, AND THE PREVIOUS SURGERY DATE IS (B)(6) 2026. THE COMPONENTS INVOLVED ARE THE FOLLOWING: - PHYSICA PS FEMUR COMP.RIGHT #5 CODE 651509150 LOT 25AS03R, STER. (B)(4). - PHYSICA FIXED TIBIAL PLATE #6 CODE 652215060 LOT 2431675, STER. (B)(4). - PHYSICA PS TIBIAL LINER #6 CODE 653550611 LOT 24AT1YG, STER. (B)(4). - PHYSICA PATELLA PROSTH. D.32MM CODE 659550032 LOT 24AT6AW, STER. (B)(4). - PHYSICA PS - FEMORAL PEG CODE 651509900 LOT 2506016, STER. (B)(4). THE PATIENT IS MALE, 67 YEARS OLD. THIS EVENT OCCURRED IN ITALY.

  Patient problems: Medical device site infection

  MAUDE report 25903388 ↗
• InjuryAug 22, 2025Unstable; Patient Device Interaction Problem; Unstable; Patient Device Interaction Problem

  KNEE REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO INSTABILITY AND PAIN. THE PATIENT WAS HAVING PAIN AND INSTABILITY IN RIGHT KNEE. THE FEMORAL COMPONENT WAS FOUND LOOSE. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED BY PHYSICA PS PRO COMPONENTS, AND THE LINER WAS REPLACED BY A HPS STABILIZED INSERT: - PHYSICA PS FEMUR COMP. RIGHT # 5 (PART CODE 6515.09.150, LOT NUMBER 21AS0DJ, STERILIZATION (B)(6)) - PHYSICA PS TIBIAL LINER #5 (PART CODE 6535.50.511, LOT NUMBER 19AT20Q, STERILIZATION (B)(6)). INSTEAD, THE TIBIAL COMPONENTS AND THE PATELLA WERE NOT REVISED: - PHYSICA FIXED TIBIAL PLATE # 5 (PART CODE 6522.15.050, LOT NUMBER 2023419, STERILIZATION (B)(6)). - PATELLAR PROSTHES.D.35 H.8.5MM (PART CODE 6595.54.035, LOT NUMBER 2110570, STERILIZATION (B)(6)). - PHYSICA TIBIAL STEM L.20MM (PART CODE 6590.15.020, LOT NUMBER 2201601, STERILIZATION (B)(6)). PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2022. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1952. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Implant Pain

  MAUDE report 22873367 ↗