Optetrak Logic 02-012-49-2011Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10885862174321), received between Oct 2, 2022 and Apr 27, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (12 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 16, 2026.

Recalls naming this device

1. Aug 30, 2021Open, 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2026Crack; Naturally Worn

  AS REPORTED, APPROXIMATELY 10 YEARS AND 6 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT PRESENTED TO THE HOSPITAL WITH SEPSIS. THE KNEE WAS NOT REALLY BOTHERING THE PATIENT UNTIL THEY BECAME SICK WITH OTHER AILMENTS. THE SURGEON EXAMINED THE LEFT KNEE AND SAW STIFFNESS FROM SWELLING, PAIN, AND DISSATISFACTION WITH THEIR TOTAL KNEE. THE PATIENT WAS SCHEDULED FOR A REVISION OF THE LEFT TOTAL KNEE ARTHROPLASTY, IRRIGATION AND DEBRIDEMENT, WITH POLYETHYLENE SWAP VS. ANTIBIOTIC SPACER PLACEMENT. THE PATIENT WAS REVISED AND UNDERWENT A TIBIAL POLY IMPLANT SWAP, AND ANTIBIOTIC BEADS WERE PLACED. IMAGES PROVIDED SHOW A CRACK AND WEAR OF THE POLYETHYLENE. THERE WAS NO REPORTED BREAKAGE OF A DEVICE, AND A 15-30 MINUTE SURGICAL DELAY/PROLONGATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain; Sepsis; Swelling/ Edema; Unspecified Infection

  MAUDE report 24997153 ↗
• MalfunctionMay 2, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD AN INITIAL KNEE IMPLANTED IN (B)(6) 2020, STATED SHE HAD EXPERIENCED PAIN FOR NEARLY TWO WEEKS. SHE VISITED THE HOSPITAL, AND THE DOCTOR RECOMMENDED AN X-RAY. THE RESULTS REVEALED THAT THE PLASTIC COMPONENT OF HER KNEE IMPLANT HAD COMPLETELY DISINTEGRATED AND WAS BREAKING INTO FRAGMENTS. NO REVISION HAS OCCURRED AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 21949690 ↗
• InjuryOct 4, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA. IT WAS REPORTED THAT APPROXIMATELY 57 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, INSTABILITY, POPPING, DISCOMFORT AND LIMITED MOBILITY. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022.

  Patient problems: Implant Pain; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 20373748 ↗
• InjuryAug 20, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (B)(4). CASE NO. (B)(4). REFER TO (B)(4) FOR RK CURRENT. IT WAS REPORTED THAT APPROXIMATELY 44 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: Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20001380 ↗
• InjuryMay 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 121 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE A FUTURE REVISION PROCEDURE DUE TO POLYETHYLENE WEAR, PAIN, SWELLING, AND INSTABILITY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Insufficient Information; Joint Laxity; Swelling/ Edema

  MAUDE report 19288926 ↗
• InjuryJan 11, 2024Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED APPROXIMATELY 9 YEARS POST OP THAT THIS 62 Y/O FEMALE PATIENT'S LEFT KNEE WAS REVISED. THE PATIENT HAD AN ORIGINAL EXACTECH TKA DONE AT (B)(6) HOSPITAL. 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 TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS FULL REVISION. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2023. THE PATIENT UNDERWENT A POLY INSERT SWAP. PATIENT WAS REVISED TO A TRULIANT CRC TIBIAL INSERT CRC SZ 2, 12MM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - THE IMPLANT(S) WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL.

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

  MAUDE report 18495843 ↗
• InjuryAug 5, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE 78 Y/O FEMALE PATIENT HAD A KNEE REVISION FOR AN UNKNOWN REASON. PATIENT WAS REVISED TO EXACTECH IMPLANTS. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS AND X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE HOSPITAL WOULD NOT ALLOW TO OBTAIN DEVICES.

  Patient problems: Discomfort; Failure of Implant; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain

  MAUDE report 17467144 ↗
• InjuryJul 6, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, APPROXIMATELY 4.4 YEARS POST INITIAL LEFT TKA, THE 72 Y/O FEMALE PATIENT RETURNED TO 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 VERSUS FULL REVISION. THE PATIENT UNDERWENT A REVISION TKA WITH A POLY SWAP AND PATELLA SWAP. PATENT WAS REVISED TO TRULIANT CRC TIBIAL INSERT SZ 2, 15MM AND OPTETRAK 3 PEG PATELLA CEMENTED 32MM. PATIENT HAD POLY DEBRIS. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE IMPLANT WAS SENT TO THE LAB AND LEGAL AT THE HOSPITAL.

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

  MAUDE report 17263858 ↗
• InjuryJun 8, 2023Naturally Worn; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Naturally Worn; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD BILATERAL KNEE REPLACEMENT WITH THEIR LEFT KNEE REPLACED ON (B)(6) 2016. THE PATIENT IS SCHEDULE TO HAVE LEFT KNEE REVISION ON (B)(6) 2023. THE REASON FOR REVISION HAS NOT BEEN PROVIDED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. 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; Implant Pain; Insufficient Information; Joint Laxity; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 17088999 ↗
• InjuryJun 6, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013 AND THEN APPROXIMATELY 9 YEARS, 9 MONTHS LATER, ON (B)(6) 2022, THEY EXPERIENCED A REVISION SURGERY WHERE THEY HAD BONE AND TISSUE LOSS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Osteolysis; Unspecified Tissue Injury

  MAUDE report 17073567 ↗
• 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, APPROXIMATELY 7 YEARS POST OP THE INITIAL RIGHT TKA, THIS 73 Y/O FEMALE PATIENT WAS REVISED DUE TO COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION. 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 HAD REVISION SURGERY ON (B)(6) 2023. THE PATIENT UNDERWENT A RIGHT TKA TIBIAL POLY SWAP AND PATELLA IMPLANT SWAP. THE PATIENT LEFT THE OR STABLE FOLLOWING FULL REVISION. DEVICES ARE NOT RETURNING, THE IMPLANT IS REQUIRED TO GO TO THE LAB AND LEGAL AT THE HOSPITAL.

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

  MAUDE report 16763686 ↗
• InjuryNov 28, 2022Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED BY LEGAL, THIS FEMALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2013. IN OR AROUND ON (B)(6) 2022, THE PATIENT WAS ADVISED THAT HER KNEE REPLACEMENT FAILED FOR REASONS RELATED TO THE DEFECTIVE DEVICE. THE PATIENT HAD A REVISION ON (B)(6) 2022 FOR ISSUES INCLUDING, BUT NOT LIMITED TO, POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, AND/OR COMPONENT LOOSENING.

  Patient problems: Failure of Implant; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 15873466 ↗
• InjuryOct 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT HAD AN INITIAL TKA ON (B)(6) 2015. THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO THE RECALL. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 15526199 ↗

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