PHYSICA Fixed Tibial Plate (REF 6522.15.090)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390092715), received between Nov 27, 2023 and May 13, 2025 — 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. How this data works · Data updated Oct 13, 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.

• InjuryMay 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE COMPLAINT SOURCE REPORTED THAT REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO A PERIPROSTHETIC INFECTION IN THE RIGHT KNEE. PREVIOUS SURGERY PERFORMED ON (B)(6) 2022. THE FOLLOWING DEVICES WERE EXPLANTED: · PHYSICA PS FEMUR COMP.RIGHT #8 (PRODUCT CODE: 6515.09.180, LOT: 17AS0T7 - STER. 2100167) - SOLD IN US · PHYSICA FIXED TIBIAL PLATE #9 (PRODUCT CODE: 6522.15.090, LOT: 2101104 - STER. 2100091)- SOLD IN US · PHYSICA PS TIBIAL LINER #9 (PRODUCT CODE: 6535.50.910, LOT: 21AT19T - STER. 2100357) - SOLD IN US · PHYSICA TIBIAL STEM L.20MM (PRODUCT CODE: 6590.15.020, LOT: 2201697 - STER. 220009) - SOLD IN US PATIENT: MALE, 55 YEARS OLD. EVENT OCCURRED IN ITALY

  Patient problems: Medical device site infection

  MAUDE report 22008375 ↗
• InjuryNov 27, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  KNEE REVISION SURGERY OF PHYSICA SYSTEM PS, PERFORMED ON (B)(6) 2023, DUE TO LOOSENING OF PHYSICA FIXED TIBIAL PLATE #9 (PRODUCT CODE 6522.15.090, LOT NR. 2102430 - STERILIZATION NR. 2100098). PATIENT IS A MALE, 38 YEARS OLD, ACCORDING TO THE RECEIVED INFORMATION THE FOLLOWING IMPLANTS GOT EXPLANTED: PHYSICA FIXED TIBIAL PLATE #9 (PRODUCT CODE 6522.15.090, LOT NR. 2102430 - STERILIZATION NR. 2100098). PHYSICA PS FEMUR COMP. LEFT #9 (PRODUCT CODE 6515.09.590, LOT NR. 20AS0EK - STERILIZATION NR. 2000245). PHYSICA PS TIBIAL LINER #9 (PRODUCT CODE 6535.50.910, LOT NR. 20AT4BS - STERILIZATION NR. 2100132) EVENT HAPPENED IN GERMANY.

  Patient problems: Implant Pain

  MAUDE report 18208228 ↗