Optetrak Logic 02-012-35-5015Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862001955), received between May 26, 2022 and Oct 10, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Naturally Worn” (5 reports).

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

2 other recalls cover devices cleared under the same FDA submission (K033883); 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.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 96 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, JOINT LAXITY, AND PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20418587 ↗
• InjuryMay 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 94 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PAIN DUE TO POLYETHYLENE WEAR, SYNOVITIS, AND OSTEOLYSIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED EXTENSIVE POLYETHYLENE SYNOVITIS, MILD PERIPROSTATIC OSTEOLYSIS, WELL-FIXED FEMORAL AND TIBIAL COMPONENT, A WELL-FIXED PATELLAR COMPONENT WITH NO SIGNIFICANT WEAR, AND EXTENSIVE PITTING AND DELAMINATION OF THE POSTERIOR ASPECT OF THE POST AND TOP SIDE OF THE INSERT MEDIALLY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. PATIENT LEFT THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Failure of Implant; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 19370333 ↗
• InjuryJul 20, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE MALE PATIENT HAD A BILATERAL KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 8 YEARS AND 5 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A BILATERAL REVISION ON (B)(6) 2022. 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 AVAILABLE. REVISION OP REPORT ON (B)(6) 2022. DIAGNOSIS: FAILED BILATERAL KNEE ARTHROPLASTY SECONDARY TO ASEPTIC FEMORAL LOOSENING AND POLYETHYLENE WEAR. FEMORAL COMPONENT WAS LOOSE WITH CYST FOUND POSTERIOR LATERAL. PATIENT WAS AWAKENED AND TAKEN TO RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Joint effusion; Synovitis

  MAUDE report 17362695 ↗
• InjuryJul 19, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD BILATERAL KNEE REPLACEMENT ON (B)(6) 2014. THEY SUBSEQUENTLY UNDERWENT RIGHT KNEE REVISION ON (B)(6) 2022, APPROXIMATELY 8 YEARS 5 MONTHS POST PRIMARY PROCEDURE. (B)(6) 2022 OP REPORT POSTOPERATIVE DIAGNOSIS: FAILED BILATERAL TOTAL KNEE ARTHROPLASTY SECONDARY TO ASEPTIC FEMORAL LOOSENING AND POLYETHYLENE WEAR. THE RIGHT PATELLA WAS FOUND TO BE WELL FIXED. THE FEMORAL COMPONENT WAS EASILY DISIMPACTED FROM THE INTACT CEMENT MANTLE. TIBIA WAS CHECKED AND WAS FOUND TO BE WELL FIXED. THERE WAS A LARGE CYST POSTERIOR LATERAL, WHICH WAS NOT DECOMPRESSED FROM THE ARTHROTOMY. 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 AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Joint effusion; Synovitis

  MAUDE report 17355901 ↗
• InjuryOct 27, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL TEAM, APPROXIMATELY TWELVE YEARS POST INITIAL RIGHT SIDE TKA, THE MALE PATIENT HAD A REVISION FOR AN UNKNOWN REASON. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Swelling/ Edema; Synovitis

  MAUDE report 15685523 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY TEN YEARS POST INITIAL TKA, THE (B)(6) MALE PATIENT HAS VERY MINIMAL BONE LYSIS UNDER THE MEDIAL TIBIAL BASE PLATE. EVENT IS ONGOING. PER CLINICAL STUDY CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND/OR PROCEDURE.

  Patient problems: Osteolysis

  MAUDE report 14518748 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033883. One submission often covers many models, so check the product and lot details in each record.

• Z-0584-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
• Z-0906-2015 · Oct 9, 2014 · Terminated
  Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants