PHYSICA TT 6521.14.050Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390169912), received between May 21, 2026 and May 21, 2026 — classified as 1 injury.

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.

• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025 REVISION OF KNEE PROTHESIS DUE TO SINTERING OF PHYSICA TT FIX. TIBIAL TRAY #5 (PRODUCT CODE: 6521.14.050, LOT: 2211436 - STER: (B)(4). DURING REVISION THE TOTAL PRIMARY KNEE HAS BEEN CHANGED TO A ROTATING HINGED KNEE. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2023. DURING ONE YEAR-CONTROL ONLY MINOR RADIOLOGIC SIGNS OF SINTERING SHOWED UP. INCREASING SINTERING WITHIN THE SECOND YEAR OF POST-OP. PATIENT DID NOT REPORT ANY TRAUMA. PRODUCT CODES AND LOT NUMBERS OF THE OTHER DEVICES IMPLANTED ON THE FIRST SURGERY ON 2023: PHYSICA TT FIX. TIBIAL TRAY #5 (PRODUCT CODE: 6521.14.050, LOT: 2211436 - STER: (B)(4), PS FEMORAL COMPONENT #5 LEFT (PRODUCT CODE: 6515.10.550, LOT: 2222424 - STER: (B)(4), PHYSICA PS TIBIAL LINER #5 (PRODUCT CODE: 6535.50.511, LOT: 22BC069 - STER: (B)(4), PHYSICA PS - FEMORAL PEG (PRODUCT CODE: 6515.09.900, LOT: 2313310 - STER: (B)(4). PATIENT: FEMALE, 75 YEARS OLD, APPROXIMATE HEIGHT 1.65(M), APPROXIMATE WEIGHT 58 (KG), ACTIVE LEVEL, NO SMOKING. EVENT OCCURRED IN AUSTRIA.

  Patient problems: Implant Pain

  MAUDE report 25238766 ↗