Optetrak Logic 02-012-48-4011Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862174499), received between Aug 17, 2022 and Sep 4, 2024 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 56 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, SEVERE PAIN, SIGNIFICANT SCARRING, SWELLING, EFFUSION, INFLAMMATION, KNEE POPPING/CLUNKING, KNEE GIVING AWAY, DIFFICULTY WALKING, ANTALGIC GAIT, AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE, AND ADDITIONAL SURGERIES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 20135699 ↗
• InjuryJul 15, 2024Naturally Worn; Naturally Worn

  APPROXIMATELY 5 YEARS AFTER INITIAL LEFT TKA, THE PATIENT WAS REVISED DUE TO WEAR ON THE PATELLA AND TIBIAL INSERT. THE PATIENT WAS NOT REVISED TO EXACTECH DEVICES. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19739968 ↗
• InjuryMay 17, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 84 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, REVISION SURGERY, CHRONIC PAIN AND SUFFERING, LOSS OF EASY MOBILITY, LOSS OF ABILITY TO DRIVE A VEHICLE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain; Pain; Swelling/ Edema

  MAUDE report 19344376 ↗
• InjurySep 12, 2023Naturally Worn; Naturally Worn

  AS REPORTED, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY (B)(6) 2016. THEY SUBSEQUENTLY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 6 YEARS 4 MONTHS POST PRIMARY PROCEDURE. REVISION SURGEON NOTED HAVING IDENTIFIED FREE FRAGMENTS OF POLYETHYLENE LINING, AND THAT THERE WAS SIGNIFICANT DAMAGE AFFECTING THE MEDIAL AND POSTEROMEDIAL ASPECT OF THE TIBIAL TRAY. BOTH FEMORAL AND TIBIAL COMPONENTS WERE SOLIDLY ANCHORED AND SO WAS THE PATELLA. 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: Failure of Implant; Swelling/ Edema; Synovitis

  MAUDE report 17732077 ↗
• InjuryAug 15, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS 72 Y/O MALE PATIENT'S LEFT KNEE WAS REVISED DUE TO WEAR. SURGEON PERFORMED A POLY AND PATELLA SWAP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING; HOSPITAL KEPT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17549249 ↗
• InjuryMay 23, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION A PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2017. APPROXIMATELY 5 YEARS AND 5 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023 DUE TO A LEFT KNEE IMPLANT FAILURE AND SYNOVITIS. REVISION OP REPORT REC'D ON (B)(6) 2023, FINDINGS: SYNOVITIS LEFT KNEE FAILED TIBIAL POLYETHYLENE BEARING OF LEFT TOTAL KNEE ARTHROPLASTY WITH POSTEROLATERAL BEARING. NO GROSS EVIDENCE OF INFECTION. STERILE DRESSINGS WERE APPLIED AND PATIENT WAS TAKEN TO RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Joint effusion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 16983836 ↗
• InjuryAug 17, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS POST OP THE INITIAL TKA, THIS MALE PATIENT SHOWED UP TO CLINIC WITH PAIN AND RECURRENT EFFUSIONS. SURGEON NOTED MODERATE POLY WEAR AND OXIDATION UPON EXAMINING THE INSERT. HE ALSO STATED THERE WAS NO SIGNIFICANT OSTEOLYSIS ON IMAGING. NEW 11CRC INSERT WAS IMPLANTED WITH GOOD ROM AND STABILITY. PATIENT LEFT IN STABLE CONDITION.

  Patient problems: Failure of Implant; Joint effusion; Pain

  MAUDE report 15240512 ↗

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