Optetrak Logic 02-012-49-2013Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862174338), received between Jan 14, 2022 and Mar 21, 2024 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023, APPROXIMATELY 7 YEARS, 3 MONTHS AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT OF (B)(6) 2023- POSTOPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE ARTHROPLASTY. THERE WAS NOTED TO BE SIGNIFICANT PIECES OF POLYETHYLENE FLOATING IN THE JOINT. THE PATIENT¿S PREVIOUS POLYETHYLENE INSERT HAD FAILED CATASTROPHICALLY. THE TIBIA WAS WELL FIXED. THE PATIENT WAS TAKEN TO RECOVERY ROOM IN STABLE CONDITION. THE DEVICES WERE NOT RETURNED, THERE ARE NO IMAGES PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Joint Laxity; Joint effusion; Osteolysis

  MAUDE report 18956049 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 5.5 YEARS POST INITIAL RIGHT TKA, THE 75 Y/O FEMALE HAD A REVISION DUE TO POLY RECALL. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS REVISED TO EXACTECH DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN X-RAYS OR IMAGES, THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS HOSPITAL KEPT THE IMPLANT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 17587406 ↗
• InjuryAug 16, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2015. APPROXIMATELY 3 YEARS AND 6 MONTHS AFTER THE FIRST RIGHT KNEE REVISION THE PATIENT HAD A SECOND RIGHT KNEE REVISION ON (B)(6) 2019. DURING THE (B)(6) 2019, REVISION SURGERY, THE SURGEON FOUND THAT THE POLYETHYLENE FAILED, HAD AN EXCESSIVE AMOUNT OF WEAR, AND WAS DEGRADING/SHEDDING POLYETHYLENE DEBRIS THAT CAUSED METALLOSIS, PAIN, SWELLING, OSTEOLYSIS, SYNOVITIS, BONE LOSS, AND TISSUE DAMAGE. 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

  MAUDE report 17555392 ↗
• InjuryApr 18, 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 LEFT TKA ON (B)(6) 2018. THE PATIENT PRESENTED BACK TO THE SURGEONS OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR LEFT TKA. THE PATIENT HAS A RECALLED IMPLANT. THE PATIENT UNDERWENT A LEFT TKA TIBIAL POLY SWAP AND PATELLA IMPLANT SWAP ON (B)(6) 2023. 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

  Patient problems: Distress; Failure of Implant; Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 16766261 ↗
• InjuryMar 1, 2023Fracture; Peeled/Delaminated; Naturally Worn; Insufficient Device Problem Information; Fracture; Peeled/Delaminated; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED BY LEGAL, APPROXIMATELY 5 YEARS POST OP THE INITIAL TKA, THIS PATIENT EXPERIENCES STIFFNESS, PAIN, AND DISCOMFORT AT THE SITE OF THE IMPLANT.

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

  MAUDE report 16459085 ↗
• InjuryOct 4, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT 3.5 YEARS POST OP, THIS FEMALE PATIENT'S RIGHT KNEE WAS REVISE DUE TO WEAR. RECALL POLY SWAP PER SURGEON REQUEST.

  Patient problems: Failure of Implant

  MAUDE report 15536412 ↗
• InjuryJul 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS FEMALE PATIENT HAD ANOTHER REVISION ON HER LEFT KNEE. REASON FOR THE REVISION WAS NOT REPORTED. PREVIOUS REVISION FOR LEFT KNEE WAS CAPTURED IN 1038671-2022-00758 / (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 14943406 ↗
• InjuryMay 17, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL LEFT TKA, THE (B)(6) FEMALE PATIENT HAD A REVISION DUE TO PHYSICIAN REQUESTED IMPLANTS FOR REVISION OF WORN INSERT. PATIENT HAD SYNOVITIS REMOVED AND PATIENT IS EXPECTING BETTER MOTION AND RELIEF OF PAIN. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL WOULD NOT ALLOW REMOVAL OF THE EXPLANT.

  Patient problems: Failure of Implant

  MAUDE report 14421752 ↗
• InjuryFeb 22, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY FOUR YEARS POST INITIAL TKA, THIS FEMALE PATIENT WAS REVISED TO A PERSONA REVISION KNEE FOR BOTH THE FEMUR AND TIBIA DUE TO PAIN, WEAR AND OSTEOLYSIS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. PHOTOS ATTACHED. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 13578653 ↗
• InjuryJan 14, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A (B)(6) WOMAN WHO HAD A LEFT TOTAL KNEE REPLACEMENT DONE FOR MEDIAL COMPARTMENT OA BACK IN 2018. PATIENT DID EXCEEDINGLY WELL AND ACHIEVED A RANGE OF MOTION (ROM) OF 0-138 DEGREES. PATIENT RESUMED FULL ACTIVITIES INCLUDING GOING TO THE GYM AND DOING LOW IMPACT EXERCISES AND RETURNED TO HER JOB AS A DENTAL ASSISTANT. PATIENT VISIT SURGEON LAST MONTH COMPLAINING OF WORSENING PROXIMAL TIBIAL PAIN AND SWELLING. NO HISTORY OF TRAUMA. NO CONSTITUTIONAL SYMPTOMS TO SUGGEST INFECTION. PATIENT EXAM SHOWED THAT SHE STILL MAINTAINED HER ROM BUT CLEARLY HAD A 1-2+ EFFUSION WITHOUT ERYTHEMA NOR UNUSUAL WARMTH. HER X-RAYS FROM (B)(6) 2021 WERE COMPARED TO HER X-RAYS FROM (B)(6) 2018 AND THIS CLEARLY SHOWED RADIOLUCENCIES AROUND THE MEDIAL FEMORAL CONDYLE, THE MEDIAL TIBIAL PLATEAU UNDER THE BASEPLATE AND AROUND THE KEEL OF THE TIBIAL BASEPLATE AS WELL. FURTHERMORE, OF GREATER CONCERN WAS THE FACT THAT HER POLY THICKNESS HAD DECREASED BY APPROXIMATELY 50%. PATIENT HAS SUBSEQUENTLY HAD A 3 PHASE BONE SCAN WHICH SHOWS INCREASED ACTIVITY IN ALL 3 OF THOSE SAME AREAS CONSISTENT WITH LOOSENING AND A MAVRIC MRI WHICH SHOWS A STRESS INJURY UNDER HER MEDIAL TIBIAL PLATEAU. HER SEROLOGY HAS

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Inflammation; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 13261194 ↗

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