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PHYSICA TT 6521.14.070Recalls & reported problems

Limacorporate SPA · Physica TT - Ti6Al4V EBM - Fixed Tibial Plate #7 Uncemented · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390174305), received between Dec 21, 2023 and May 6, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Patient Device Interaction Problem2

Patient problems

  • Insufficient Information2

Recent adverse event reports

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

  • InjuryMay 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

    REVISION SURGERY ON (B)(6) 2025, DUE TO FAILED POROUS LIMA TIBIAL COMPONENT: TIBIA COLLAPSED AND NEEDED FULL REVISION. THE FOLLOWING COMPONENTS WERE REVISED:Z - PHYSICA PS - FEMORAL PEG (PART CODE 6515.09.900, LOT NUMBER 2322178, STERILIZATION 2300215). - PS FEMORAL COMPONENT #8 RIGHT (PART CODE 6515.10.180, LOT NUMBER 2316633, STERILIZATION 2300195). - PHYSICA TT FIX. TIBIAL TRAY #7 (PART CODE 6521.14.070, LOT NUMBER 2212388, STERILIZATION 2200277). - PHYSICA PS TIBIAL LINER #7 (PART CODE 6535.50.710 , LOT NUMBER 22BC06J, STERILIZATION 2200263). - PATELLAR PROSTHES.D.38 H.10MM (PART CODE 6595.54.038, LOT NUMBER 22AT1V6, STERILIZATION 2300228). THE REMOVED DEVICES WERE REPLACED BY THIRD-PARTY COMPONENTS. SURGERY WAS COMPLETED AS INTENDED. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2023. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1951. THE EVENT HAPPENED IN THE UNITED STATES.

    Patient problems: Insufficient Information

    MAUDE report 21966608 ↗
  • InjuryDec 21, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

    KNEE REVISION SURGERY PERFORMED ON (B)(6) 2023, DUE TO EARLY MOBILIZATION OF PHYSICA TT FIX. TIBIAL TRAY #7 (PRODUCT CODE: 6521.14.070, LOT NR. 2218966, STER. NR. 2200275). DURING THE PROCEDURE PHYSICA CEMENTED TIBIAL PLATED SIZE 7 WAS IMPLANTED. THE FOLLOWING DEVICES WERE EXPLANTED DURING REVISION: PHYSICA TT FIX. TIBIAL TRAY #7 (PRODUCT CODE: 6521.14.070, LOT NR. 2218966, STER. NR. 2200275). PHYSICA PS TIBIAL LINER #7 (PRODUCT CODE: 6535.50.710, LOT. NR. 22BC06G, STER. NR. 2200141). THE FOLLOWING DEVICES REMAINED IMPLANTED: PHYSICA PS - FEMORAL PEG (PRODUCT CODE: 6515.09.900, LOT. NR. 1811518, STER. NR. 1800255). FEMORAL COMPONENT #7 LEFT (PRODUCT CODE: 6515.10.570, LOT NR. 2109698, STER. NR. 2100357) EVENT OCCURRED IN ITALY.

    Patient problems: Insufficient Information

    MAUDE report 18377652 ↗

Other Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices

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Sources and updates

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