Optetrak Logic 02-012-45-2515Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862003928), received between Jun 6, 2025 and Dec 30, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• InjuryDec 30, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 7 YEARS POST OP INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THIS WAS REVISED DUE TO POLY WEAR AND FEMORAL AND TIBIAL COMPONENTS ASEPTIC LOOSENING. ALL COMPONENTS WERE REPLACED WITH A REVISION KNEE SYSTEM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening

  MAUDE report 23921667 ↗
• InjuryJun 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY NINE YEARS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS BROUGHT BACK FOR RIGHT KNEE PAIN. THE POLY INSERT WAS REMOVED WITH THE HELP OF AN OSTEOTOME. THE TIBIA WAS CHECKED AND FOUND TO BE LOOSE AND REMOVED. THE FEMUR WAS CHECKED AND FOUND TO BE LOOSE AND REMOVED. THE PATIENT WAS REVISED TO A KNEE SIZE 2 TRULIANT LOGIC CC FEMUR, PRESS FIT STEMS, SIZE 1 TIBIA AND A 17 CC INSERT. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Implant Pain

  MAUDE report 22160867 ↗