Optetrak Logic 02-012-49-3011Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10885862174420), received between Mar 29, 2022 and Dec 10, 2024 — classified as 14 injuries.

The most frequently reported specific device problem is “Naturally Worn” (13 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 1 YEAR AND 5 MONTHS POST THE INITIAL TOTAL KNEE ARTHROPLASTY, THE PATIENT EXPERIENCED A FALL AND INJURED HIS RIGHT KNEE. THE PATIENT UNDERWENT A BONE SCAN WHICH WAS REPORTED TO SHOW INCREASED UPTAKE IN THE RIGHT PATELLA REGION, THOUGHT TO BE DUE TO POSSIBLE LOOSENING OF THE PATELLA BUTTON, AND HYPERAEMIA AT THE RIGHT TIBIAL TUBERCLE IN KEEPING WITH LIGAMENTOUS INSERTIONAL CHANGE AND UPTAKE WAS OTHERWISE UNREMARKABLE IN RELATION TO THE RIGHT KNEE PROSTHESIS. THE BONE SCAN CONFIRMED THAT THE PATIENT HAS SUBSEQUENTLY DEVELOPED COMPONENT LOOSENING. THE SURGEON RECOMMENDED THAT THE PATIENT UNDERGO A REVISION TOTAL KNEE REPLACEMENT WITH CEMENT FIXATION OF THE DEVICES. THE SURGEON FOUND A FEMUR AND PATELLA HOTSPOT ON BONE. THE PATIENT WAS REVISED TO PS AND THE PATELLA WAS CHANGED. THE FEMUR HAD NO ON-GROWTH. THE PATIENT'S HEALTH WAS STABLE LEAVING THE OPERATING ROOM. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain

  MAUDE report 20895000 ↗
• InjuryOct 28, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 81 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER: (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20549142 ↗
• InjuryOct 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 44 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20359452 ↗
• InjurySep 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 63 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20180568 ↗
• InjurySep 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 52 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20162574 ↗
• InjuryAug 14, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 102 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19981199 ↗
• InjuryJul 18, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4) THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN (B)(6) WITH MASTER CASE NO. (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Insufficient Information; Pain; Swelling/ Edema

  MAUDE report 19778688 ↗
• InjuryJul 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 88 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19643542 ↗
• InjuryJun 27, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 90 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. INITIAL SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19629350 ↗
• InjuryJun 7, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, THE PATIENT RETURNED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED POLY IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED FOR A REVISION TKA POSSIBLE POLY SWAP VS. FULL REVISION. THE PATIENT WAS REVISED AND UNDERWENT A TIBIAL POLY SWAP WITH BONE AUGMENTATION USING CEMENT BEHIND THE MEDIAL FEMORAL CONDYLE AND THE TIBIA PLATEAU. THE ORIGINAL POLY IMPLANT WAS BROKEN IN PIECES POSTERIORLY AND THE SURGEON REMOVED ALL VISIBLE POLY PIECES FROM THE WOUND AND JOINT. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

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

  MAUDE report 19487490 ↗
• InjuryOct 20, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 6.5 YEARS POST INITIAL RIGHT TKA, THE 61 Y/O FEMALE PATIENT HAD AN ELECTIVE SWAP OF A RECALLED POLY. THE PATIENT WAS REVISED TO A EXACTECH DEVICE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN IMAGES OR X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL DOES NOT ALLOW TO RETURNED THE DEVICE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17980995 ↗
• InjuryFeb 14, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL LEFT SIDE TKA, THE 78 Y/O MALE PATIENT PRESENTED BACK AND WAS SCHEDULED FOR A REVISION OF THE TOTAL KNEE POSSIBLE POLY SWAP DUE TO POLY WEAR, FAILURE, AND RECALL. A TIBIAL INSERT POLY SWAP AND A PATELLA IMPLANT REVISION WERE PERFORMED. THERE WAS A 30-45 MINUTES SURGICAL DELAY/PROLONGATION; HOWEVER, PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF SURGICAL PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS AND IMAGES RECEIVED. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16373397 ↗
• InjuryNov 3, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL BRIEF, ON OR ABOUT (B)(6) 2012, PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS IN HIS RIGHT KNEE. SUBSEQUENTLY, ON OR ABOUT (B)(6) 2020, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO A FAILED RIGHT TOTAL KNEE ARTHROPLASTY. FOLLOWING THE REVISION SURGERIES, THE PATIENT "CONTINUES TO BE LIMITED IN HIS ACTIVITIES OF DAILY LIVING, AND EXPERIENCES DAILY PAIN AND DISCOMFORT IN BOTH HIS LEFT AND RIGHTS KNEES."

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Discomfort; Erosion; Failure of Implant; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Unspecified Musculoskeletal problem

  MAUDE report 15720278 ↗
• InjuryMar 29, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY NINE YEARS POST INITIAL RIGHT TKA, THIS (B)(6) MALE PATIENT'S POLY HAD SEVERE POSTERIOR WEAR. WAS REVISED TO SIZE 3 CRC 15MM POLY. PATIENT STABLE AFTER IMPLANTATION. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY.

  Patient problems: Failure of Implant

  MAUDE report 13938235 ↗

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