Optetrak Logic 02-012-51-4009Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10885862230485), received between Feb 19, 2022 and Jan 27, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Naturally Worn” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 3 YEARS 2 MONTHS POST INITIAL OPERATION. PATIENT HAD A POLY EXCHANGED DUE TO INFECTION. DEBRIDEMENT, ANTIBIOTICS AND IMPLANT RETENTION (DAIR) WAS PERFORMED. LINER WAS EXCHANGED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21249254 ↗
• InjuryOct 8, 2024Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 4 YEARS 6 MONTHS POST INITIAL OPERATION. THE PATIENT REPORTED PAIN, INSTABILITY, AND DISSATISFACTION. THE PATIENT HAS RECALLED A TIBIAL POLY INSERT. THE PATIENT UNDERWENT A RIGHT KNEE REVISION, A FEMORAL COMPONENT REVISION, AND A POLY REVISION WAS PERFORMED DUE TO KNEE INSTABILITY. THE PATIENT WAS REVISED TO FEMORAL CC REVISION COMPONENT AND PSC POLY IMPLANT. THE SURGEON WANTED TO UPSIZE THE FEMUR COMPONENT FOR SIZING AND TO CLOSE THE EXTENSION GAP KNOWING IT IS OFF-LABEL WHEN KEEPING THE CURRENT TIBIA IMPLANT SIZE. THE TIBIA COMPONENT WAS WELL FIXED, AND THE SURGEON TRAILED THE REVISION SIZES. THE SURGEON WAS HAPPY WITH THE ARTICULATION AND STABILITY. THE PATIENT WAS IMPLANTED WITH THE CC REVISION FEMORAL COMPONENT AND NEW PSC POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Joint Laxity; Osteolysis; Pain

  MAUDE report 20397075 ↗
• InjurySep 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 114 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. INITIAL 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: Insufficient Information

  MAUDE report 20183955 ↗
• InjurySep 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 108 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SWELLING, PAIN, AND BONE LOSS; PROPHYLACTIC FIXATION OF RIGHT FEMUR, BONE GRAFTING OF LYTIC LESIONS. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20183618 ↗
• InjuryMay 20, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 96 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, DISCOMFORT AND WEAKNESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19355438 ↗
• InjuryJan 11, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS 53 Y/O FEMALE PATIENTS RIGHT KNEE WAS REVISED 1.5 YEARS POST OP. THE PATIENT WAS REVISED DUE TO OSTEOLYSIS, LOOSENING AND POLY WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO PRODUCT RETURN; DISPOSED AT HOSPITAL.

  Patient problems: Osteolysis

  MAUDE report 18499081 ↗
• InjuryDec 4, 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 AN UNKNOWN DATE. THE PATIENT RETURNED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY, AND DISSATISFACTION WITH THEIR TKA. THE PATIENT HAD A RECALLED IMPLANT. UPON EXAMINATION, THE PATIENT WAS SCHEDULED TO HAVE A REVISION TKA POSSIBLE POLY SWAP VS. A FULL REVISION. THE PATIENT WAS REVISED ON (B)(6) 2023 AND THE TIBIAL POLY IMPLANT WAS SWAPPED. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Joint Laxity; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 18263948 ↗
• InjuryJul 20, 2023Fracture; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Fracture; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN ORIGINAL EXACTECH TKA, THEN APPROXIMATELY FIVE YEARS POST INITIAL TKA, THE 68 Y/O MALE 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 VS FULL REVISION. THE PATIENT UNDERWENT A TKA FULL REVISION TO A DIFFERENT COMPETITOR'S DEVICE. THERE WERE PIECES OF THE POLY THAT WERE BROKEN OFF AND REMOVED. THERE WAS A SURGICAL DELAYED OF GREATER THAN 45 MINUTES DUE TO PATIENT UNDERWENT LONGER THAN EXPECTED SURGERY WHEN NEEDING TO DO A FULL REVISION. PATIENT REQUIRED PROLONGED HOSPITALIZATION AS A DIRECT RESULT OF THIS ISSUE. HOWEVER, PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THE SURGICAL DELAY/PROLONGATION. IMAGES RECEIVED. 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 17361592 ↗
• InjuryMay 31, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 6.5 YEARS POST OP INITIAL LEFT TKA, THIS 79 Y/O MALE PATIENT WAS REVISED DUE TO POLY WEAR. SURGEON REVISED LINER AND PETALLA. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING, DISPOSED BY HOSPITAL.

  Patient problems: Failure of Implant

  MAUDE report 17030351 ↗
• InjuryMar 1, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL RIGHT TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2016 AND WAS IMPLANTED WITH AN OPTETRAK DEVICE. PLAINTIFF UNDERWENT REVISION SURGERY OF HIS RIGHT KNEE ON (B)(6) 2022, APPROXIMATELY 6 YEARS 7 MONTHS POST INITIAL PROCEDURE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Insufficient Information; Joint effusion; Pain; Synovitis

  MAUDE report 16461090 ↗
• InjuryNov 29, 2022Loss of or Failure to Bond; Naturally Worn; Loss of or Failure to Bond; Naturally Worn

  IT WAS REPORTED A 68 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2014, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 8 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED TO THE SURGEON¿S OFFICE WITH CONSISTENT COMPLAINTS OF PAIN, STIFFNESS, AND SWELLING. IT HAD BEEN PREVIOUSLY ASPIRATED IN THE OFFICE. THE X-RAYS TAKEN SHOWED POSSIBLE OSTEOLYSIS AND MADE THE SURGEON QUESTION IF THE IMPLANTS WERE WELL FIXED WITHIN THE KNEE. THE POLY IMPLANT WAS RUN IN THE RECALL DATABASE AND DID COME BACK AS AN AFFECTED POLY WITHIN THE CURRENT KNEE POLY RECALL. THE PATIENT WAS THEN SCHEDULED FOR A LEFT TKA REVISION POSSIBLE POLY SWAP. THE SURGEON PERFORMED A SYNOVECTOMY. THE SURGEON REQUESTED AND TOOK CULTURES FROM THE DEEP JOINT FLUID. IT WAS MENTIONED THAT WERE WAS OBVIOUS OSTEOLYSIS AND TISSUE INFLAMMATION WITHIN AND AROUND THE JOINT. THE SURGEON THEN REMOVED THE POLY IMPLANT AND CHECKED THE METAL COMPONENTS TO CHECK IF THEY WERE WELL FIXED. THE POLY IMPLANT SHOWED SIGNIFICANT WEAR, INCLUDING PITTING AND DELAMINATION ON THE ARTICULAR SURFACE. THE SURGEON WAS ABLE TO PULL THE PRIMARY FEMORAL IMPLANT OFF THE PATIENT'S FEMUR BONE WITH HIS HAND. THE METAL IMPLAN

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

  MAUDE report 15882686 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED VIA A LEGAL TOLLING AGREEMENT, THAT A MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2020, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021 APPROXIMATELY 1 YEAR 8 MONTHS POST THE INITIAL IMPLANT PROCEDURE FOR UNKNOWN REASONS. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15394986 ↗
• InjuryJul 11, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4 YEARS PORT OP THE INITIAL RIGHT TKA, THIS 52 Y/O MALE PATIENT WAS REVISED DUE TO POLY WEAR AND THE POLY BEING SLIGHTLY DELAMINATED. PARTS AND PIECES WERE REMOVED FROM PATIENT BY THE SURGEON, HE PULLED THE POLY OUT AND IRRIGATED THE WOUND W 3000 CC OF ANTIBIOTIC. THERE WAS A 5-15 MIN SURGICAL DELAY, NO ADVERSE EVENT AS A RESULT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS NOT RETURNING.

  Patient problems: Failure of Implant

  MAUDE report 14975712 ↗
• InjuryFeb 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY FOURTEEN MONTHS POST INITIAL RIGHT SIDE TKA, THIS (B)(6) MALE PATIENT HAD A REVISION DUE TO INFECTION. PATIENT HAD PAIN AND SWELLING. THERE WAS NO BREAKAGE OF THE DEVICE. THERE WAS LESS THAN 5 MINUTES SURGICAL DELAY/PROLONGATION. NO ADVERSE EVENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. REP WAS UNABLE TO OBTAIN X-RAYS OR PHOTOS. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: Bacterial Infection

  MAUDE report 13565350 ↗