Optetrak Logic 02-012-51-4013Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862230508), received between Apr 6, 2023 and Apr 3, 2026 — classified as 9 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.

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.

• InjuryApr 3, 2026Naturally Worn; Lack of Effect

  AS REPORTED, APPROXIMATELY 6 YEARS AND 2 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT PRESENTED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF STIFFNESS FROM SWELLING, PAIN, AND DISSATISFACTION WITH THEIR TOTAL KNEE. DECREASED MOTION WAS PRESENT. THE PATIENT WAS SCHEDULED FOR A REVISION OF THEIR RIGHT TOTAL KNEE ARTHROPLASTY, WITH A POSSIBLE POLYETHYLENE SWAP. THE PATIENT WAS REVISED AND UNDERWENT A TIBIAL POLY IMPLANT SWAP AND PATELLA IMPLANT SWAP. IMAGES PROVIDED SHOW WEAR OF THE TIBIAL INSERT AND PATELLA COMPONENTS. 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: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 24784281 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 3 YEARS AND 11 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT HAD A KNEE LINER EXCHANGE DUE TO THE POLY RECALL AND SWELLING AND PAIN. THE LINER WAS IN PRISTINE CONDITION, NOT WORN. 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: Pain; Swelling/ Edema

  MAUDE report 23003366 ↗
• InjuryJan 13, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY AND THEN APPROXIMATELY 1 YEAR, 9 MONTHS LATER, THE PATIENT EXPERIENCED A REVISION SURGICAL PROCEDURE. THE PATIENT WAS REVISED TO A COMPETITOR'S DEVICES. REVISION OPERATIVE REPORT STATES- FAILED TKA SECONDARY SEPTIC LOOSENING. X-RAYS DEMONSTRATED LOOSENING OF TIBIAL AS WELL AS PATELLAR COMPONENT. ASPIRATED KNEE, IT WAS SIGNIFICANT FOR RED BLOOD CELLS AS WELL AS 12,000 WHITE BLOOD CELLS WITH 100% NEUTROPHIL DIFFERENTIAL- NOTHING GREW FROM THE ASPIRATION. PATELLAR COMPONENT WAS COMPLETELY LOOSE. REMOVED ANY REMAINING CEMENT. FEMORAL COMPONENT WAS GROSSLY LOOSE.... REMOVED THE TIBIAL COMPONENT, IT WAS GROSSLY LOOSE. NO APPARENT COMPLICATIONS NOTED. THERE IS NO CLINICAL/PATIENT MEDICAL INFORMATION PROVIDED. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Inadequate Osseointegration; Inflammation; Joint Laxity; Medical device site infection; Pain; Unspecified Infection

  MAUDE report 21143290 ↗
• InjuryAug 12, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT THIS 70 Y/O MALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 5 YEARS 2 MONTHS POST OP. THE PATIENT HAD AN ORIGINAL EXACTECH TKA, THEN 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 FOR A REVISION TKA POSSIBLE POLY SWAP VS. FULL REVISION. THE PATIENT UNDERWENT A TIBIAL POLY SWAP WITH BONE AUGMENTATION USING CEMENT BEHIND THE FEMORAL CONDYLES AND THE TIBIA PLATEAU. PATIENT LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Implant Pain; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19968841 ↗
• InjuryJul 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 76 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 19756385 ↗
• InjuryMay 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 60 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 19320382 ↗
• InjuryOct 11, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2018. THE PATIENT RETURNED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAS A RECALLED IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS. FULL REVISION. THE PATIENT WAS REVISED ON (B)(6) 2023. THE PATIENT UNDERWENT A POLY TIBIAL INSERT SWAP WITH EXACTECH, AND A PATELLA IMPLANT SWAP USING A COMPETITORS DEVICE. THE EXACTECH REP FORGOT TO RESET THE PAN WITH THE PATELLA DRILL, SO THE COMPETITOR COMPANY HAD A PATELLA PAN AVAILABLE AND AN IMPLANT AVAILABLE THAT WAS USED. 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; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 17917178 ↗
• InjuryJul 17, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2015. APPROXIMATELY 7 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. 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) 2022. DIAGNOSIS: FAILED LEFT KNEE ARTHROPLASTY DUE TO RECURRENT EFFUSIONS FROM POLYETHYLENE AND FLEXION INSTABILITY - FEMORAL COMPONENT FOUND TO BE DEBONDED "COPIOUS STRAW-COLORED SYNOVIAL FLUID WAS OBTAINED. I THEN SENT SYNOVIAL SPECIMENS FOR CULTURE AS WELL AS FROZEN PATHOLOGY. A GENEROUS MEDIAL PEEL WAS PERFORMED TO ASSIST WITH EXPOSURE. A PARTIAL SYNOVECTOMY WAS PERFORMED TO REESTABLISH THE MEDIAL AND LATERAL GUTTERS. NEXT, THE POLYETHYLENE WAS REMOVED WITH AN OSTEOTOME. THERE WAS NO GROSS EVIDENCE OF POLYETHYLENE WEAR. THE FEMUR WAS THEN EASILY ABLE TO BE DISIMPACTED. THE IMPLANT WAS FOUND TO BE COMPLETELY DE BONDED FROM THE UNDERLYING CEMENT." THE PATIENT WAS ROUSED FROM ANESTHESIA, HAVING TOLERATED THE PROCEDURE WELL WITHOUT COMPLICATION. HE WAS BROUGH

  Patient problems: Failure of Implant; Joint effusion; Pain

  MAUDE report 17335351 ↗
• InjuryApr 6, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE LEGAL TEAM; SECOND REVISION OPERATIVE REPORT: PREOPERATIVE DIAGNOSIS- FAILED TOTAL LEFT KNEE ARTHROPLASTY. 58 YEAR OLD MALE WITH END-STAGE OSTEOARTHRITIS OF THE LEFT KNEE, STATUS POST TOTAL KNEE ARTHROPLASTY. HE HAS A FAILURE OF THE TIBIAL COMPONENT WITH CYSTIC FORMATION. KNEECAP WAS EVERTED, TRICOMPARTMENTAL OSTEOARTHRITIC CHANGES WERE NOTED. PATELLA WAS EVALUATED, WAS PRISTINE AND WAS NOT REMOVED. OSTEOPHYTE FROM THE SUPERIOR POLE OF THE PATELLA WAS REMOVED. EXTENSIVE DEBRIDEMENT AND SYNOVECTOMY SHARPLY DONE. THE FEMUR WAS REMOVED. MINIMAL BONE LOSS WAS ENCOUNTERED. THERE WAS EXCELLENT FIXATION OF THE COMPONENT, BUT THEY WERE ABLE TO REMOVE IT WITH THE SAW BLADE AND THIN OSTEOPHYTE. THE SURGEON THEN TURNED ATTENTION TO THE TIBIA AND USING A SIMILAR SYSTEM, THE TIBIA WAS LOOSE. USING THE OSTEOTOME AND SAW, THE SURGEON WAS ABLE TO REMOVE IT WITH THIS TRYING TO LIMIT THE AMOUNT OF BONE LOSS. THERE WAS A LARGE CYST ON THE PROXIMAL TIBIA THAT HAD BEEN SEEN ON THE X-RAY. THIS WAS DEBRIDED AND REMOVED. TIBIAL AND FEMORAL COMPONENTS WERE REPLACED.,11MM INSERT USED. STERILE DRESSING WAS APPLIED, THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION.

  Patient problems: Cyst(s); Extraskeletal ossification; Failure of Implant

  MAUDE report 16687799 ↗