Optetrak Logic 02-012-35-6011Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862001979), received between Sep 8, 2023 and Feb 5, 2025 — classified as 9 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 (K093360); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 93 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, AMBULATION DIFFICULTIES, DISCOMFORT, PAIN, JOINT EFFUSION, SCAR TISSUE, AND OSTEOLYSIS. INITIAL SURGERY AND 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; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint effusion; Osteolysis; Pain; Scar Tissue

  MAUDE report 21312528 ↗
• InjuryJan 22, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 8 YEARS POST OP INITIAL LEFT TKA, THIS 56 Y/O MALE PATIENT WAS REVISED DUE TO A LOOSENING FEMUR. PATIENT ALSO COMPLAINED OF KNEE PAIN. EXPLANTED AND REVISED WITH COMPETITORS DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNKNOWN MEDICAL HISTORY. NO PHOTOS OR X-RAYS PROVIDED. PRODUCT IS NOT BEING RETURNED DUE TO HOSPITAL POLICY.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Implant Pain

  MAUDE report 21207551 ↗
• InjuryJan 3, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 77 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING FAILURE OF IMPLANT, JOINT EFFUSION, JOINT LAXITY, PAIN, AND SYNOVITIS. 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: Failure of Implant; Joint Laxity; Joint effusion; Pain; Synovitis

  MAUDE report 21071697 ↗
• InjurySep 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 151 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND SYNOVITIS. OP REPORT NOTED POLY HAD SEVERE WEAR PATTERN AND PULSED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Synovitis

  MAUDE report 20124918 ↗
• InjuryAug 27, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 35 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 20075598 ↗
• InjuryApr 24, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2014. THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO KNEE PAIN AND INSTABILITY AND THE POLY WAS EXCHANGED FOR A PSC 13MM. 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: Failure of Implant; Implant Pain; Joint Laxity

  MAUDE report 19177891 ↗
• InjuryMar 12, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6)2023, APPROXIMATELY 8 YEARS, 6 MONTHS AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT OF (B)(6) 2023- POSTOPERATIVE DIAGNOSIS: FAILURE OF RIGHT KNEE PROSTHESIS. THE POLYETHYLENE INSERT WAS REMOVED USING AN OSTEOTOME. THERE WAS BURNISHING, OBVIOUS POLYETHYLENE WEAR, AND OSTEOLYSIS. THE PATIENT WAS REVISED TO COMPETITOR¿S COMPONENTS. THE PATIENT WAS AWOKEN FROM ANESTHESIA AND TAKEN TO THE PACU IN STABLE CONDITION. THE DEVICES WERE NOT RETURNED, THERE ARE NO IMAGES PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Osteolysis

  MAUDE report 18889246 ↗
• InjuryNov 13, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 6 YEARS AND 4 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. 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. REVISION OP REPORT ON (B)(6) 2023 DIAGNOSIS: FAILED TOTAL LEFT KNEE THERE WAS DIFFUSE SYNOVIAL PROLIFERATION WITH TAN-COLORED AND HYPERVASCULAR STAINING TO THE SYNOVIAL LINING OF THE JOINT. THE POLYETHYLENE LINER WAS LOCKED IN THE TIBIAL TRAY, AND THERE WAS MINIMAL WEAR OF THE ARTICULAR SURFACE OF THE LINER (MEDIAL CORNER OF POSTEROLATERAL ARTICULAR ASPECT, MILD LATERAL POST EROSIVE WEAR, UNDERSURFACE INTACT) AS WELL AS GROOVING AND DELAMINATION ON THE LATERAL ASPECT OF THE PATELLAR BUTTON. THE FEMORAL COMPONENT DEBONDED FROM THE CEMENT WITH EASE. THERE WAS A LARGE UNCONTAINED DEFECT ANTERIORLY. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 18121058 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INFLAMMATION ON (B)(6) 2015. THE PATIENT PRESENTED ON (B)(6) 2018 AND AFTER VERY ACTIVE END OF THE YEAR DEVELOPED LEFT KNEE EFFUSION WITH PAIN. EFFUSION NEVER WENT AWAY SO CAME IN FOR F/U. RADIOGRAPHIC IMAGES SHOWED NO CHANGES BUT NOTED EFFUSION ON LATERAL VIEW. ASPIRATION NEGATIVE FOR INFECTION. WILL CONTINUE TO MONITOR. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICE, UNLIKELY RELATED TO PROCEDURE.

  Patient problems: Failure of Implant; Implant Pain; Joint effusion

  MAUDE report 17710200 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093360. One submission often covers many models, so check the product and lot details in each record.

• Z-2310-2012 · Aug 19, 2011 · Terminated
  OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. There are three produ