Optetrak Logic 02-010-01-0360Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862001276), received between Aug 9, 2024 and Nov 26, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K093360); 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.

• InjuryNov 26, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015 AND THEN APPROXIMATELY 8 YEARS LATER ON (B)(6) 2023 EXPERIENCED A SURGICAL REVISION. REVISION OPERATIVE REPORT OF (B)(6) 2023 -REVISION RIGHT TOTAL KNEE (TIBIAL, FEMORAL AND POLYETHYLENE). THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, LOOSE FEMORAL IMPLANT, SYNOVITIS AND PAIN. FINDINGS: LOOSE FEMORAL IMPLANT- REMOVED EASILY WITH MODERATE BONE LOSS. EXCESSIVE WEAR OF POLYETHYLENE WITH SIGNS OF OXIDATION/YELLOW DISCOLORATION, PITTING, CRACKING AND DELAMINATION OF THE POLY. DISTAL FEMORAL BONE LOSS WAS MODERATE. THE TIBIAL BONE LOSS WAS EXTENSIVE AND REPAIRED WITH A TIBIAL CONE. PATELLA BUTTON WAS STABLE AND NOT REVISED. PATIENT WAS TAKEN TO PACU IN STABLE CONDITION. THERE IS NO OTHER PATIENT OR MEDICAL INFORMATION PROVIDED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Synovitis

  MAUDE report 20785616 ↗
• InjuryAug 13, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 120 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Pain; Synovitis

  MAUDE report 19975728 ↗
• InjuryAug 9, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  **08-AUG-2024 ADDITIONAL SUMMARY** IT IS REPORTED VIA LEGAL DOCUMENTATION THAT PATIENT UNDERWENT RK REVISION (B)(6) 2024.(OP REPORT ATTACHED). CLINICAL HISTORY: PATIENT PRESENTS WITH FAILED RIGHT TOTAL KNEE REPLACEMENT IN THE SETTING OF RECALLED IMPLANT, WITH OSTEOLYSIS OF THE DISTAL FEMUR AND HE PROXIMAL TIBIA. PRE/POSTOPERATIVE DIAGNOSIS: STATUS POST RIGHT TOTAL KNEE REPLACEMENT; DISTAL FEMUR AND PROXIMAL TIBIA OSTEOLYSIS. PROCEDURE: REVISION TOTAL KNEE REPLACEMENT FEMORAL AND TIBIAL COMPONENTS OPERATIVE NOTES: KNEE JOINT EXPOSED. PATELLA WAS DISLOCATED LATERALLY AND FOUND TO BE STABLE. INSERT WAS REMOVED. FEMORAL COMPONENT WAS FOUND TO BE LOOSE. BONY INVENTORY AFTER REMOVAL OF THE FEMORAL COMPONENT REVEALED AORI TYPE 2B BONE LOSS. TIBIAL COMPONENT WAS THEN REMOVED, DURING THIS TIME A SMALL DEFECT WAS NOTED IN THE POSTERIOR CORTEX OF THE PROXIMAL TIBIA, WHICH WAS LATER FILLED WITH CERAMENT. BONY INVENTORY AFTER REMOVAL CEMENT OF THE TIBIA REVEALED AORI TYPE 1 BONE LOSS. TRIAL COMPONENTS WERE SIZED, THEN REMOVED. CERAMENT WAS USED TO FILL THE DEFECT IN THE POSTERIOR TIBIAL CORTEX. BONY SURFACES WERE THEN IRRIGATED AND DRIED. IMPLANTS WERE IMPACTED. PATIENT WAS TRANSFERRED TO THE R

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Pain

  MAUDE report 19947963 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093360. One submission often covers many models, so check the product and lot details in each record.

• 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-2310-2012 · Aug 19, 2011 · Terminated
  OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. There are three produ