Optetrak Logic 02-012-44-6013Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862173874), received between Mar 9, 2023 and Jul 26, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0021-2022 · Root cause: Process control · Recall details · FDA record ↗

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.

• InjuryJul 26, 2024Mechanical Problem; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 42 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, JOINT PAIN, JOINT SWELLING, JOINT STIFFNESS, LIMITED RANGE OF MOTION, LOSS OF MOBILITY, MUSCLE TISSUE DAMAGE, TISSUE DAMAGE, DEVICE FAILURE NECESSITATING PAINFUL REVISION SURGERY; LIMITED ACTIVITIES, DAILY PAIN AND DISCOMFORT IN LEFT KNEE IMPACTING QUALITY OF LIFE. SIGNIFICANT PAIN AND DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING,; COMPONENT PART LOOSENING, SOFT TISSUE DAMAGE, BONE LOSS, AND OTHER UNDIAGNOSED INJURIES REQUIRING ONGOING MEDICAL CARE. FUTURE DAMAGES ALSO INCLUDING BUT NOT LIMITED TO COST OF MEDICAL CARE, REHABILITATION, HOME HEALTH CARE, LOSS OF EARNING CAPACITY, MENTAL AND EMOTIONAL DISTRESS, LOSS OF CONSORTIUM AND PAIN AND SUFFERING. . NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19837451 ↗
• InjurySep 5, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 3.5 YEARS POST OP INITIAL RIGHT TKA, THIS 72 Y/O MALE PATIENT WAS REVISED. PATIENT PRESENTED WITH A SORE KNEE AFTER A FALL FROM A LADDER. AFTER OPENED THE KNEE, SURGEON FOUND POLY AND OSTEOLYSIS ISSUE. THIS SEEMS TO BE FROM THE PATELLA WEAR. LINER AND PATELLA WERE EXCHANGED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PHOTOS & X-RAYS ATTACHED. PRODUCT NOT RETURNING - IT WAS DISCARDED.

  Patient problems: Joint effusion; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 17682323 ↗
• InjuryMar 9, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL RIGHT KNEE REPLACEMENT SURGERY IN 2015. HE WAS IMPLANTED WITH AN OPTETRAK DEVICE. ON (B)(6) 2023, PLAINTIFF IS SCHEDULED TO UNDERGO RIGHT KNEE REVISION SURGERY, APPROXIMATELY 8 YEARS 2 MONTHS POST INITIAL PROCEDURE, TO REMOVE THE FAILED POLYETHYLENE LINER DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE POLYETHYLENE TIBIAL INSERT. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Implant Pain; Joint Laxity; Pain; Synovitis

  MAUDE report 16518214 ↗