Optetrak Logic 02-012-48-5009Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862174581), received between Apr 26, 2022 and Jan 11, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Naturally Worn” (7 reports).

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

1 other recall cover devices cleared under the same FDA submission (K111400); 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED 5.5 YEAR POST INITIAL RIGHT TKA, THIS 64 Y/O MALE PATIENT WAS REVISED. KNEE WAS LEAKING FLUID OUTSIDE CAPSULE, POSSIBLY DUE TO POLY WEAR CAUSING IT BUT SURGEON WAS NOT SURE AFTER TAKING LINER OUT UNCERTAIN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN PHOTOS/X-RAYS. PRODUCT NOT RETURNING: DISPOSED BY HOSPITAL.

  Patient problems: Bacterial Infection; Bursitis; Joint Laxity; Synovitis

  MAUDE report 18498602 ↗
• InjuryNov 15, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL RIGHT TKA, THE 69 Y/O MALE PATIENT HAD A REVISION DUE TO POLY WEAR. ALL IMPLANTS WERE REMOVED. 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 THEY WERE DISCARDED BY THE HOSPITAL.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18145211 ↗
• InjuryAug 25, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION OUS, THAT A PATIENT HAD BILATERAL KNEE REPLACEMENT ON (B)(6) 2016. IT IS REPORTED THAT THE PATIENT¿S RIGHT KNEE HAS EXPERIENCED ONGOING COMPLAINTS SINCE THIS PROCEDURE REQUIRING REVISION SURGERY. 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 OTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 17624733 ↗
• InjuryAug 24, 2023Loss of Osseointegration; Insufficient Device Problem Information; Loss of Osseointegration; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT KNEE ARTHROPLASTY REVISION ON (B)(6) 2023, APPROXIMATELY 7 YEARS, 1 MONTH AFTER IMPLANT DUE TO OSTEOLYSIS, ALL IMPLANTS WERE REMOVED. THE PATIENT WAS NOT REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF DEVICES. THERE WAS NO SURGICAL DELAY/PROLONGATION. THERE IS NO MEDICAL/CLINICAL HISTORY AVAILABLE. THERE ARE NO PHOTOS OR IMAGES AVAILABLE. THE DEVICE WILL NOT RETURN, IT WAS DISPOSED OF BY THE FACILITY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Pain

  MAUDE report 17612152 ↗
• InjuryJul 6, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013 AND THEN APPROXIMATELY 9 YEARS, 6 MONTHS LATER EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023. PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. REVISION OPERATIVE REPORT OF (B)(6) 2023. PREOPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL KNEE REPLACEMENT DUE TO POLY WEAR. INDICATIONS FOR PROCEDURE: THE PATIENT HAD A PREVIOUS TOTAL KNEE ARTHROPLASTY PERFORMED AND WAS DIAGNOSED TO HAVE SYMPTOMATIC POLY WEAR IN A RECALLED IMPLANT. THE PATIENT HAS HAD CONTINUED PAIN AND PROBLEMS. FULL INFECTION WORKUP AND IT WAS NEGATIVE. PROCEDURE: THEY EXPOSED THE JOINT AND CLEARED OUT THE SUPRA-PATELLAR POUCH, MEDIAL AND LATERAL GUTTERS OF THE SCAR TISSUE AND THICKENED SYNOVIUM TO HELP WITH MOBILIZATION OF THE PATELLA. THEY EVALUATED THE PATELLA TO DETERMINE WHAT TO DO WITH THE REMAINING PATELLA. THEY CLEANED OFF THE MEMBRANE AROUND THE EDGES OF PATELLAR BUTTON. THE BUTTON WAS IN GOOD SHAPE WITHOUT ANY WEAR, THEY DECIDED TO LEAVE IT AND REMOVE LATERAL OVERHANGING OSTEOPHYTES. THEY WERE ABLE TO REMOVE THE FEMORAL COMPONENT WITH MINIMAL BONE LOSS. THEY HAD MINIMAL TIBIAL BONE LOSS. AFTER COM

  Patient problems: Failure of Implant; Pain

  MAUDE report 17266732 ↗
• InjuryJun 5, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION A PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 5 YEARS AND 7 MONTHS AFTER THE INITIAL SURGERY THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2021. 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; Failure of Implant; Inflammation; Insufficient Information; Medical device site infection; Osteolysis

  MAUDE report 17061568 ↗
• InjuryJun 2, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2018, APPROXIMATELY 5 YEARS LATER, ON (B)(6) 2023 THE PATIENT EXPERIENCED A REVISION SURGERY FOR PAIN, STIFFNESS, AND WEAKNESS. 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; Discomfort; Osteolysis; Pain

  MAUDE report 17050063 ↗
• InjuryMay 11, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2016. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO POLY WEAR. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16915721 ↗
• InjuryMar 7, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY THREE YEARS POST INITIAL RIGHT SIDE TKA, THE 75 Y/O MALE PATIENT HAD A REVISION DUE TO POLY WEAR, PATIENT'S INSERT WAS REVISED. THERE WAS NO BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. IMAGES RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISPOSED BY THE HOSPITAL.

  Patient problems: Failure of Implant

  MAUDE report 16497047 ↗
• InjuryApr 26, 2022Naturally Worn; Naturally Worn

  AS REPORTED BY THE LEGAL TEAM, APPROXIMATELY THREE YEARS POST INITIAL TKA, THIS (B)(6)MALE PATIENT INDICATES THAT PATIENT WAS DIAGNOSED WITH MECHANICAL FAILURE. PATIENT UNDERWENT REVISION SURGERY DUE TO SIGNIFICANT POLYETHYLENE WEAR AND CYSTIC FORMATION WITHIN THE PROXIMAL TIBIA AND THE DISTAL FEMUR. FOLLOWING THE REVISION SURGERY, PATIENT CONTINUES TO BE LIMITED IN ACTIVITIES OF DAILY LIVING, PATIENT HAS DIFFICULTY WITH DAILY ACTIVITIES SUCH AS GETTING DRESSED, CLIMBING STAIRS, AND BATHING. FURTHERMORE, DESPITE UNDERGOING THE REVISION SURGERY, PATIENT EXPERIENCES DAILY PAIN AND DISCOMFORT IN LEFT KNEE WHICH LIMITS PATIENT¿S ACTIVITIES OF DAILY LIVING AND IMPACTS PATIENT QUALITY OF LIFE.

  Patient problems: Failure of Implant

  MAUDE report 14212599 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111400. One submission often covers many models, so check the product and lot details in each record.

• Z-0583-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013