Optetrak Logic 02-012-49-3013Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862174437), received between Feb 8, 2022 and May 20, 2024 — classified as 7 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 (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS AND 5 MONTHS POST THE INITIAL TKA, THE 60 YEAR OLD FEMALE PATIENT RETURNED TO THE SURGEON'S 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) 2024. THERE WAS EXTENSIVE SYNOVITIS THAT WAS DEBRIDED. THERE WAS OSTEOLYSIS BEHIND THE LATERAL FEMORAL CONDYLE AND UNDER THE MEDIAL POSTERIOR TIBIA IMPLANT. BOTH THE FEMORAL COMPONENT AND THE TIBIAL COMPONENT WERE TESTED FOR LOOSENING AND SHOWED TO BE STABLE/NOT LOOSE. THE PATIENT UNDERWENT A POLY TIBIAL INSERT SWAP AND PATELLA SWAP. 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; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19350238 ↗
• InjuryNov 16, 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 73 Y/O FEMALE PATIENT HAD AN ORIGINAL EXACTECH TKA DONE ON (B)(6) 2018. THE PATIENT RETURNED TO SURGEON'S 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. THE PATIENT HAD REVISION SURGERY ON (B)(6) 2023. THE PATIENT UNDERWENT A POLY INSERT SWAP AND PATELLA IMPLANT SWAP. PATIENT WAS REVISED TO A TRULIANT CRC TIBIAL INSERT CRC SZ 3, 15MM AND OPTETRAK 3 PEG PATELLA CEMENTED 29MM. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS ATTACHED . THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE IMPLANT(S) WERE SENT TO THE LAB AND LEGAL AT THE HOSPITAL.

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

  MAUDE report 18148975 ↗
• InjuryJul 5, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, APPROXIMATELY 6 YEARS POST OP INITIAL RIGHT TKA, THIS 76 Y/O MALE PATIENT WAS REVISED. THE PATIENT RETURNED TO SURGEONS 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 HAD REVISION SURGERY ON (B)(6) 2023. THE PATIENT UNDERWENT A TKA FULL REVISION TO ANOTHER COMPANY REVISION KNEE DUE TO A DAMAGED POLY LOCKING MECHANISM IN THE EXACTECH KNEE DUE TO POLY WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THERE IS NO KNOWN MEDICAL HISTORY FOR THIS PATIENT. TWO X RAYS WERE PROVIDED. THE PRODUCT IS NOT BEING RETURNED DUE TO THE IMPLANT WAS SENT TO THE LAB AND LEGAL AT THE HOSPITAL.

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

  MAUDE report 17262465 ↗
• InjuryApr 10, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED BY THE LEGAL TEAM, ON (B)(6) 2018, PATIENT UNDERWENT SURGERY UTILIZING RECALLED EXACTECH COMPONENT PARTS. NO PATIENT REVISION SCHEDULED. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT PATIENT PRESENTED BACK TO SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR RIGHT 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 HAD REVISION SURGERY ON (B)(6) 2023. THE PATIENT UNDERWENT A RIGHT TKA TOTAL IMPLANT REVISION TO COMPETITORS DEVICE DUE TO A BENT/MALFUNCTIONING LOCKING MECHANISM OF THE EXACTECH TIBIAL BASEPLATE, A POLY EXCHANGE WAS NOT POSSIBLE. THE LOCKING MECHANISM WAS DAMAGED DUE TO THE POLY WEAR AND METAL-ON-METAL IMPLANT CONTACT. THERE WAS NO BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT LEFT THE OPERATING ROOM (OR) STABLE FOLLOWING FULL REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE RECALLED POLY INSERT WAS REQUIRED TO BE SENT TO THE LAB AND LEGA

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

  MAUDE report 16710475 ↗
• InjuryOct 5, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  THIS FEMALE PATIENT HAS REPORTED PAIN AND SUFFERING. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 15546865 ↗
• InjuryApr 20, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 3.5 YEARS POST INITIAL RIGHT TKA, THIS (B)(6) MALE PATIENT HAD A TOTAL KNEE REPLACEMENT WHICH FAILED. PATIENT REASON FOR THE REVISION WAS POLY FAILURE. THERE IS LOTS OF POLY WEAR AND IT HAD A SANDPAPER TEXTURE TO IT. IT WAS DISCOLORED AND YELLOW IN SPOTS. THERE WAS OSTEOLYSIS. SURGEON SAW THE PATIENT IN CLINIC AND RECOGNIZED A FAILING COMPONENT. PATIENT REVISED TO COMPETITOR'S DEVICE. THERE WAS NO PARTS OR PIECES FELL INTO THE PATIENT WOUND SITE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 14161293 ↗
• InjuryFeb 8, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS POST INITIAL LEFT SIDE TKA, THIS (B)(6) FEMALE PATIENT EXPERIENCED PROGRESSIVE INSTABILITY OVER TIME THAT BROUGHT HER BACK TO THE CLINIC. POLY WEAR OVER TIME OF BOTH COMPARTMENTS. POSTERIOR WEAR BILATERALLY BUT WORSE MEDIALLY. IT WAS NOT PUT IN TOO TIGHT POSTERIORLY AND THE KNEE WAS WELL BALANCED. WHEN SURGEON TOOK POLY OUT AND REPLACED IT THERE WAS NO POSTERIOR TIGHTNESS. THERE WAS NO PARTS OR PIECES FELL INTO THE PATIENT WOUND SITE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 13485882 ↗

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