Optetrak Logic 02-012-51-2511Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862230379), received between Apr 28, 2023 and Sep 12, 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.

• InjurySep 12, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 36 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SEVER PAIN, SIGNIFICANT SCARRING, SWELLING, EFFUSION, INFLAMMATION, KNEE POPPING/CLUNKING, KNEE INSTABILITY, DIFFICULTY WALKING, ANTALGIC GAIT, SYNOVITIS , ADDITIONAL SURGERIES, ANXIETY AND EMOTIONAL DISTRESS.. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Joint Laxity; Joint effusion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20199065 ↗
• InjuryJun 26, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY REVISION ON (B)(6) 2016 AND THEN APPROXIMATELY 6 YEARS LATER HAD A SURGICAL REVISION ON (B)(6) 2022. THE PATIENT WAS REVISED TO EXACTECH DEVICES. REVISION OPERATIVE REPORT OF (B)(6) 2022 -TO REVISE LEFT TIBIA AND TIBIAL POLY; FOR OTHER MECHANICAL COMPLICATIONS OF INTERNAL LEFT KNEE PROSTHESIS. PROCEDURE: CLEAR SYNOVIAL FLUID WAS NOTED ONCE THE JOINT WAS ENTERED. THE JOINT HAD OBVIOUS EVIDENCE OF POLYETHYLENE WEAR DEBRIS WITH DIFFUSE CLUSTERS OF WHITE SYNOVITIS. DELAMINATION ON THE MEDIAL ASPECT OF THE TIBIAL POLYETHYLENE WAS IMMEDIATELY NOTED. A COMPLETE SYNOVECTOMY WAS ACCOMPLISHED. THE FEMUR WAS INSPECTED AND WAS RIGIDLY FIXED WITH NO EVIDENCE OF LOOSENING. THE TIBIAL COMPONENT WAS REMOVED AND THERE WAS EXTENSIVE OSTEOLYSIS MEDIALLY. NEW DEVICES WERE FITTED AND IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. THE PATIENT WAS AWAKENED AND TRANSFERRED TO RECOVERY IN GOOD CONDITION AFTER APPLICATION OF A BULKY STERILE DRESSING. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL I

  Patient problems: Emotional Changes; Osteolysis; Pain; Synovitis

  MAUDE report 17198686 ↗
• InjuryApr 28, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT IS VERIFIED RIGHT KNEE DONE ON (B)(6) 2017. SHE HAD THE RIGHT KNEE REVISED ON (B)(6) 2022, APPROXIMATELY 5 YEARS 7 MONTHS AFTER THEIR INITIAL PROCEDURE. POSTOPERATIVE DIAGNOSIS: RIGHT KNEE ARTHROFIBROSIS WITH INSTABILITY, MORBID OBESITY WITH BODY MASS INDEX OF 43. THE POLYETHYLENE WAS NOTED TO HAVE "SIGNIFICANT POSTERIOR POLYETHYLENE WEAR." THE OTHER IMPLANTS WERE ADEQUATELY POSITIONED AND WELL FIXED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO FURTHER INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 16829466 ↗