Optetrak Logic 02-012-49-3511Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885862159328), received between Oct 4, 2021 and May 19, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Naturally Worn” (12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Unstable; Naturally Worn; Lack of Effect

  IT WAS REPORTED THAT A PATIENT, WHO HAD A RIGHT TKA, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 7 YEARS 3 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED TO THE SURGEON WITH COMPLAINTS OF PAIN, STIFFNESS, SWELLING, DECREASED MOTION, AND DISSATISFACTION. THE PATIENT HAD A RECALLED KNEE POLYETHYLENE LINER, WHICH WAS WORN OUT ON THE X-RAY. THE PATIENT UNDERWENT A POLY INSERT SWAP FROM A SLOPE ++ TO A CRC ACTIVIT-E IMPLANT. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN AS IT IS HANDLED BY THE HOSPITAL. A DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 25224572 ↗
• InjuryNov 11, 2024Fracture; Unstable; Naturally Worn; Fracture; Unstable; Naturally Worn

  AS REPORTED, THE PATIENT HAD A PRIMARY LEFT TOTAL KNEE ARTHROPLASTY (TKA) IN 2015. THE PATIENT PRESENTED BACK WITH COMPLAINTS OF PAIN, SWELLING, AND DISSATISFACTION WITH THEIR TKA. AFTER EXAMINATION, THE PATIENT WAS SCHEDULED FOR REVISION SURGERY. THE PATIENT UNDERWENT A POLYETHYLENE IMPLANT EXCHANGE. THERE WERE FREE-FLOATING PIECES OF POLYETHYLENE FLOATING IN THE KNEE JOINT AND ATTACHED TO THE SOFT TISSUE ONCE OPENING UP THE CAPSULE OF THE KNEE JOINT. THE PIECES WERE REMOVED ALONG WITH THE POLY IMPLANT. THE KNEE JOINT WAS IRRIGATED WELL. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION AFTER SURGERY.

  Patient problems: Discomfort; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20660059 ↗
• InjuryOct 24, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT HAD AN ORIGINAL EXACTECH TOTAL KNEE ARTHROPLASTY (TKA) ON THEIR RIGHT SIDE. THE PATIENT RETURNED TO SURGEONS 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 TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT UNDERWENT A POLY TIBIAL INSERT SWAP AND PATELLA SWAP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. PRODUCT WILL NOT BE RETURNED; THE IMPLANT(S) WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL.

  Patient problems: Joint Laxity; Joint effusion; Pain

  MAUDE report 20523763 ↗
• InjuryOct 8, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, APPROXIMATELY 7 YEARS AND 9 MONTHS POST THE INITIAL RIGHT TKA, THE PATIENT RETURNED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY AND DISSATISFACTION WITH THEIR RIGHT TKA. THE PATIENT HAS A RECALLED POLY IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT UNDERWENT A POLY TIBIAL INSERT SWAP AND PATELLA SWAP. THE PATIENT WAS REVISED TO EXACTECH DEVICES. 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.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20404222 ↗
• InjuryAug 13, 2024Mechanical Problem; Unstable; Naturally Worn; Mechanical Problem; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 64 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SWELLING, STIFFNESS, ARTHROFIBROSIS S/P INITIAL SURGERY. REVISION 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Joint effusion; Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 19971118 ↗
• InjuryJul 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 30 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SCARRING, SWELLING, EFFUSION, INFLAMMATION, KNEE GIVING AWAY, DIFFICULTY WALKING, ANTALGIC GAIT, AND SYNOVITIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Joint effusion; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 19690201 ↗
• InjuryMay 14, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 48 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS . NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19310733 ↗
• InjuryJul 24, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2016. THE SURGERY HASN¿T BEEN CONFIRMED. THE PATIENT SAID HIS RIGHT KNEE POPS OUT ALL THE TIME, AND HE HAS FELT PAIN IN HIS RIGHT KNEE FOR OVER A YEAR. 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: Insufficient Information; Osteolysis; Synovitis

  MAUDE report 17379766 ↗
• InjuryJul 7, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2013. THE PATIENT WAS REVISED DUE TO THE POLY BEING WORN OVER TIME. SLOPE++ WAS SHAPED WITH A CRC POLY. THERE WAS NO REPORTED BREAKAGE OF 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 17276645 ↗
• InjuryFeb 9, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, APPROXIMATELY 4 YEARS POST OP THE INITIAL LEFT TKA, THIS 70 Y/O MALE PATIENT WAS REVISED. SURGEON PREFORMED A POLY SWAP DUE TO RECALL POLY, POLY WEAR, OSTEOLYSIS.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 16333664 ↗
• InjuryJan 26, 2022Naturally Worn; Naturally Worn

  AS REPORTED, PATIENT PRESENTED WITH PAIN AND INSTABILITY AND WAS SCHEDULED FOR A RIGHT REVISION TKA POSSIBLE POLY SWAP. UPON REVISION, THE POLY INSERT WAS REMOVED AND APPEARED TO BE BROKEN INTO PIECES POSTERIORLY. THE POLY WAS NOT INTACT AND SHOWED ABNORMAL WEAR. THE METAL FEMUR AND TIBIA IMPLANTS WERE WELL FIXED, AND THE PATIENT OBTAINED A POLY SWAP AFTER TRAILING WITH A CRC SIZE 13MM INSERT, A NEW CRC SIZE 3.5, 13MM POLY WAS IMPLANTED. THE PATIENT WAS REVISED FROM AN 11MM, 3.5 ++ POLY TO A 13MM 3.5 CRC POLY. THE SURGEON REMOVED AND IRRIGATED OUT THE PARTS/PIECES FROM THE KNEE. THE PATIENT LEFT THE OR ROOM STABLE. THE POLY AND ITS PIECES WERE CONTAINED, SAVES, AND WILL BE RETURNED TO MANUFACTURER.

  Patient problems: Failure of Implant

  MAUDE report 13362074 ↗
• InjuryOct 4, 2021Naturally Worn; Naturally Worn

  AS REPORTED, A MALE, (B)(6), WEIGHT IS UNKNOWN, INITIAL IMPLANT OF (B)(6) 2019. PRIMARY LEFT KNEE CASE WAS PERFORMED (B)(6) 2019, PCL RUPTURED AS PER X-RAY. HE HAD L3/4 SPINE ISSUES AND WEAK QUADS BECAUSE OF BACK. HAD SPINE OPERATION FEW WEEKS AGO. POLY WEAR NOTED IN PROVIDED X-RAYS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL RETURN.

  Patient problems: Failure of Implant

  MAUDE report 12569147 ↗

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