Optetrak Logic 02-012-51-3015Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862230430), received between Sep 29, 2022 and Sep 26, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 69 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SIGNIFICANT PAIN AND DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, SOFT TISSUE DAMAGE, BONE LOSS; COST OF MEDICAL CARE, REHABILITATION, HOME HEALTH CARE, LOSS OF EARNING CAPACITY, MENTAL AND EMOTIONAL DISTRESS, 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; Osteolysis; Pain

  MAUDE report 20309028 ↗
• InjuryFeb 21, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6)2023, APPROXIMATELY 4 YEARS, 10 MONTHS AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT OF (B)(6) 2023- POSTOPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE. PATELLA WAS REVISED TO AN OPTETRAK 3 PEG PATELLA, 32 MM DIAMETER AND A TRULIANT POLYETHYLENE LINER WAS PLACED. PATIENT EXPERIENCED PAIN, IMAGING WAS CONSISTENT WITH POSSIBLE SYMPTOMATIC POLYETHYLENE WEAR. THE POLYETHYLENE WAS REMOVED AND SHOWED OXIDATION AND MILD WEAR. THERE WAS NO LOOSENING NOTED WITH IMPACTION. PATIENT WAS THEN WOKEN FROM SEDATION AND TRANSFERRED TO RECOVERY IN STABLE CONDITION. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE. REVISION OP REPORT ATTACHED.

  Patient problems: Failure of Implant

  MAUDE report 18754711 ↗
• InjuryAug 21, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL LEFT TKA, THE 73 Y/O FEMALE PATIENT RETURNED TO SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS FULL REVISION. THEREFORE, THE PATIENT UNDERWENT POLY TIBIAL INSERT SWAP AND PATELLA IMPLANT SWAP. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THE IMPLANTS WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL.

  Patient problems: Failure of Implant; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 17586623 ↗
• InjurySep 29, 2022Mechanical Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A FEMALE PATIENT, INITIAL RIGHT TOTAL KNEE REPLACEMENT SURGERY, (B)(6) 2016, BEGAN TO SUFFER FROM SYMPTOMS ASSOCIATED WITH THE DEFECTS OF EXACTECH KNEE SYSTEM AS ALLEGED IN THIS COMPLAINT, INCLUDING PAIN AND LACK OF MOBILITY. AS A RESULT OF THESE SYMPTOMS, PLAINTIFF UNDERWENT REVISION SURGERY ON (B)(6) 2022 APPROXIMATELY 6 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. NO FURTHER INFORMATION KNOWN.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Implant Pain; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 15503037 ↗