Optetrak Logic 02-010-01-0310Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862001207), received between Sep 21, 2020 and Dec 10, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K033883); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 96 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PAIN, STIFFNESS, SWELLING AND LOSS OF MOBILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ankylosis; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 20895887 ↗
• InjuryFeb 14, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 70 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2015, UNDERWENT A REVISION PROCEDURE ON (B)(4) 2024, APPROXIMATELY 8 YEARS 2 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT COMPLAINED OF PAIN AND INSTABILITY. THE FEMUR APPEARED GROSSLY LOOSE ON X-RAY PER THE SURGEON. THE PATIENT WAS REVISED TO A 02-010-06-0310 LOGIC CC FEMORAL SIZE 1 RIGHT A244027, 02-010-06-0511 LOGIC POST. AUG. BLOCK SIZE 1 5MM 6811390, 02-012-60-1480 LOGIC STEM EXT 14MM X 80MM 6613674, 02-012-61-2000 LOGIC OFFSET STEM EXT COUPLER 2MM A299460, 02-022-44-1009 TRULIANT TIB IMP PSC INSERT SZ 1 9MM M000273, AND A 208-05-01 CC DISTAL FEM AUGMENT SZ 1 5MM 7028916. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS FOR ANALYSIS AVAILABLE DUE TO THE HOSPITAL POLICY. NO FURTHER INFORMATION.

  Patient problems: Joint Laxity; Pain

  MAUDE report 18707247 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 6 YEARS POSTOP THE INITIAL TIGHT TKA, THIS FEMALE, PATIENT WAS REVISED DUE TO OSTEOLYSIS. THE PATIENT HAS A HISTORY OF OSTEOARTHRITIS. THE PATIENT REQUIRED A DISTAL FEMORAL REPLACEMENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE TO DE RETURNED.

  Patient problems: Osteolysis

  MAUDE report 10561019 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033883. One submission often covers many models, so check the product and lot details in each record.

• Z-0584-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
• Z-0021-2022 · Aug 30, 2021 · Open, Classified
  OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts,
• Z-0906-2015 · Oct 9, 2014 · Terminated
  Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants