Optetrak Logic 02-012-47-4011Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862174451), received between Dec 14, 2021 and Sep 20, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Naturally Worn” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 122 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 20268356 ↗
• InjuryAug 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 87 MONTHS AFTER A RIGHT 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 19990175 ↗
• InjuryJul 2, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 4 YEARS AND 11 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT, THE PATIENT PRESENTED WITH A SORE KNEE AND WAS REVISED. ALL IMPLANTS WERE REMOVED AND REPLACED WITH A COMPETITOR'S KNEE SYSTEM. THE EVENT IS 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. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISPOSED OF BY THE CUSTOMER. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain

  MAUDE report 19662084 ↗
• InjuryMay 24, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 119 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, PATELLAR COMPONENT LOOSENING, PAIN AND SWELLING. 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: Ambulation or Postural Difficulties; Failure of Implant; Implant Pain; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19391077 ↗
• InjuryMay 20, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 94 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEARCHRONIC PAIN, SUFFERING AND FEAR OF FURTHER MOBILITY LOSS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Pain; Swelling/ Edema

  MAUDE report 19351851 ↗
• InjuryJul 14, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 4 YEARS 2 MONTHS POST INITIAL TKA, THE PATIENT WAS REVISED DUE TO PAIN AND SYNOVITIS. THE SURGEON STATED THAT THE SYNOVITIS WAS MILD AND THE INSERT WAS PITTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Implant Pain; Pain

  MAUDE report 15020986 ↗
• InjuryDec 15, 2021Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5.5 YRS POSTOP THE INITIAL IMPLANT, THIS (B)(6) PATIENT HAD A REVISION DUE INCREASE WEAR ON THE TIBIAL SURFACE. REPLACED THE POLY INSERT WITH A SIZE 4, 11MM CRC INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS AVAILABLE FOR RETURN/EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 13010436 ↗
• InjuryDec 14, 2021Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YRS POSTOP THE INITIAL L TKA THIS (B)(6) MALE PATIENT PRESENTING WITH COMPLAINING OF SWELLING OF HIS LEFT KNEE FOR THE PAST 2 YEARS FOLLOWED BY INSTABILITY AND WAS SCHEDULED FOR A REVISION DUE TO INCREASE WEAR ON LEFT TIBIAL SURFACE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 13006131 ↗

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