Optetrak Logic 02-012-44-1511Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862173447), received between May 11, 2021 and Jan 28, 2025 — 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.

• InjuryJan 28, 2025Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 6 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2019. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: PROTHESIS WEAR, LOOSENING, PAIN, DIFFICULTY WITH EVERYDAY ACTIVITIES, TROUBLE WALKING. PATIENT WAS REVISED TO EXACTECH DEVICES. REVISION OPERATIVE REPORT OF (B)(6) 2019- POSTOPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL KNEE ARTHROPLASTY-SECONDARY TO ASEPTIC LOOSENING. PROCEDURE: A SYNOVECTOMY WAS PERFORMED. THE PATELLA WAS SUBLUXATED. THE POLYETHYLENE WAS EXTRACTED. THE FEMORAL COMPONENT WAS GROSSLY LOOSE WITH SEVERE DISTAL FEMORAL BONE NECROSIS. THE RESIDUAL NECROTIC BONE WAS REMOVED WITH RONGEURS AND CURETTES. REMOVED THE TIBIAL COMPONENT WITHOUT DIFFICULTY. THE PATELLA COMPONENT REMAINED WELL-FIXED. STERILE DRESSINGS WERE APPLIED, THE PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM. NO OTHER INFORMATION IS AVAILABLE. 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 INFORMATION IS AVAI

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Aseptic loosening; Joint effusion; Necrosis; Pain; Synovitis

  MAUDE report 21255400 ↗
• InjuryJan 2, 2025Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 3 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2016. THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: PAIN, DIFFICULTY WITH EVERYDAY ACTIVITIES, TROUBLE WALKING. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO 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. POSTOPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO ASEPTIC FEMORAL AND TIBIAL LOOSENING. PROCEDURE: THERE IS SIGNIFICANT HYPERTROPHIC INFLAMMATORY SYNOVITIS A COMPLETE SYNOVECTOMY WAS PERFORMED. ON INSPECTION OF THE COMPONENTS OF THE PATELLA, COMPONENT WAS WELL FIXED. THE FEMORAL AND TIBIAL COMPONENTS WERE GROSSLY LOOSE THEY WERE EXTRACTED THERE IS NECROTIC BONE BENEATH THE COMPONENTS. RESIDUAL CEMENT AND FIBRINOUS DEBRIS WAS REMOVED. DEVICES WERE TRAILED AND THEN THE IMPLANTS SEATED. ALL WERE ASSESSED AND FOUND TO BE SATISFACTORY. THE PATIENT WAS AWAKENED AND TRANSFERRE

  Patient problems: Ambulation or Postural Difficulties; Pain; Synovitis

  MAUDE report 21061229 ↗
• InjuryJun 2, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD RIGHT KNEE REPLACEMENT ON (B)(6)2018. THEY UNDERWENT REVISION SURGERY ON (B)(6) 2020, APPROXIMATELY 2 YEARS 6 MONTHS AFTER THEIR INITIAL IMPLANTATION. THE REASON FOR REVISION HAS NOT BEEN DISCLOSED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO 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; Bone Fracture(s); Implant Pain; Insufficient Information; Joint Laxity; Scar Tissue; Synovitis; Unspecified Infection

  MAUDE report 17049769 ↗
• InjuryMay 11, 2021Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 1.5 YR POST INITIAL L TKA, THIS (B)(6) Y/O FEMALE PATIENT HAD A LEFT KNEE REVISION DUE TO INSTABILITY. INSERT WAS CHANGED FROM 11MM TO A 15MM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS THE DEVICE WAS DISPOSED BY HOSPITAL. ONLY THE INSERT WAS REVISED PER THE EXPERIENCE REPORT.

  Patient problems: Failure of Implant; Joint Laxity; Pain

  MAUDE report 11806223 ↗