Optetrak Logic 02-012-44-2013Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10885862173492), received between Aug 11, 2020 and Feb 11, 2025 — classified as 21 injuries.

The most frequently reported specific device problem is “Naturally Worn” (15 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 28 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, AMBULATION DIFFICULTIES, DISCOMFORT, IMPLANT PAIN, JOINT LAXITY, METAL RELATED PATHOLOGY, OSTEOLYSIS, SCAR TISSUE, AND SWELLING/EDEMA. 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: Ambulation or Postural Difficulties; Discomfort; Implant Pain; Joint Laxity; Metal Related Pathology; Osteolysis; Scar Tissue; Swelling/ Edema

  MAUDE report 21358257 ↗
• InjuryJan 9, 2025Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT. APPROXIMATELY 6 YEARS AND 4 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Osteolysis; Pain

  MAUDE report 21118681 ↗
• InjuryJan 2, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 42 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND SWELLING. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED RIGHT KNEE POLYETHYLENE ASSOCIATED SYNOVITIS AND RIGHT KNEE LATERAL PATELLAR SPUR. INTRAOPERATIVELY, THE SURGEON OBSERVED PROLIFERATIVE SYNOVITIS IN THE MEDIAL GUTTER, A SIGNIFICANT LATERAL PATELLAR SPUR. IT WAS NOTED THAT THE EXISTING POLYETHYLENE INSERT SHOWED SOME EVIDENCE OF POSTEROMEDIAL WEAR. THE FEMORAL COMPONENT AND TIBIAL COMPONENT WERE TESTED MANUALLY FOR STABILITY AND DID NOT DEMONSTRATE ANY INSTABILITY INTRA-OPERATIVELY. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain; Swelling/ Edema; Synovitis

  MAUDE report 21061931 ↗
• InjuryAug 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 103 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PLAINTIFF EXPERIENCES DAILY PAIN AND DISCOMFORT WHICH LIMITS HER ACTIVITIES OF DAILY LIVING AND IMPACTS HER QUALITY OF LIFE. PAIN, SWELLING, PERIPROSTHETIC OSTEOLYSIS, POLYMERIC WEAR, BONE LOSS AND/OR COMPONENT LOOSENING. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19973166 ↗
• InjuryJun 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 6 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 19500024 ↗
• InjuryJun 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 59 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19472510 ↗
• InjuryJun 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 8 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, AND WEAKNESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED.

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

  MAUDE report 19463214 ↗
• InjuryMay 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 43 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, LOOSE FEMORAL COMPONENT, SYNOVITIS, OSTEOLYSIS, PAIN, AND INSTABILITY. 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.

  Patient problems: Failure of Implant; Implant Pain; Joint Laxity; Osteolysis; Synovitis

  MAUDE report 19319055 ↗
• InjuryDec 14, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2015. APPROXIMATELY 7 YEARS AND 6 MONTHS AFTER THE FIRST REVISION THE PATIENT HAD A SECOND 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: POLYETHYLENE FAILURE. THERE WAS A VAGUS CUTE IN THE FEMUR AND THEREFORE THEY REMOVED THE POLY. THERE WAS SIGNIFICANT OSTEOLYSIS. THEY COULD SEE WAVE IN THE FLUID AND THE SYNOVITIS.

  Patient problems: Failure of Implant; Osteolysis; Synovitis

  MAUDE report 18326851 ↗
• InjuryOct 23, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 8 YEARS AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. THE PATIENT EXPERIENCED PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS. 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. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044 (NGG) (MMH), AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Insufficient Information; Joint Laxity; Osteolysis; Pain; Synovitis

  MAUDE report 17987388 ↗
• InjuryJun 7, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2018. APPROXIMATELY 3 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. PATIENT HAS CLAIMED THE FOLLOWING IN JURIES AND COMPLICATIONS: ARTHRALGIAS, PAIN AND JOINT SWELLING, SYNOVITIS, OSTEOLYSIS. 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; Failure of Implant; Insufficient Information; Osteolysis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 17078190 ↗
• InjuryMay 9, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2012. APPROXIMATELY 10 YEARS AND 4 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REPLACEMENT ON 6 JAN 2023. 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: Insufficient Information

  MAUDE report 16894652 ↗
• InjuryFeb 28, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2009, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2011, IN WHICH THE OPTETRAK LOGIC TIBIAL INSERTS MADE OF POLYETHYLENE WERE REMOVED AND REPLACED WITH ANOTHER OPTETRAK DEVICE. THE PLAINTIFF RECEIVED A LETTER IN OR AROUND APRIL OF 2022 INFORMING HER THAT HER OPTETRAK DEVICE HAD BEEN RECALLED. UPON INFORMATION AND BELIEF, AS A RESULT OF THE 2011 OPTETRAK DEVICE FAILING, THE PLAINTIFF UNDERWENT ANOTHER REVISION SURGERY ON HER RIGHT KNEE ON (B)(6) 2022, APPROXIMATELY 10 YEARS 7 MONTHS POST THE 2011 REVISION PROCEDURE FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, AND/OR COMPONENT LOOSENING. THE PLAINTIFF EXPERIENCES DAILY PAIN AND DISCOMFORT IN HER KNEE WHICH LIMITS HER ACTIVITIES OF DAILY LIVING AND IMPACTS HER QUALITY OF LIFE. NO DEVICE RETURNS ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION. FIRST REVISION REPORTED UNDER 1038671-2023-00278.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Insufficient Information; Osteolysis; Pain; Synovitis

  MAUDE report 16457471 ↗
• InjuryFeb 13, 2023Adverse 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 THAT A PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2014, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 8 YEARS 1 MONTH POST THE INITIAL PROCEDURE. REASON FOR THE REVISION IS UNKNOWN. THE PATIENT HAD A 2 X 13 PSC INSERT, AND THE SURGEON TRIALED WITH A 15 THEN A 17 AND DECIDED A 2 X 19 PSC INSERT WAS THE MOST STABLE. NO DEVICE RETURN ANTICIPATED. THE HOSPITAL KEPT IT. NO FURTHER INFORMATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 16369011 ↗
• InjurySep 2, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL FILING THAT A FEMALE PATIENT WHO HAD AN INITIAL RIGHT KNEE IMPLANT PROCEDURE ON (B)(6) 2013, CLAIMED SHE SUSTAINED INJURIES RESULTING FROM HER KNEE PROSTHESIS, AND WAS REVISED APPROXIMATELY 8 YEARS AND 8 MONTHS POST HER INITIAL PROCEDURE. NO FURTHER INFORMATION KNOWN. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION FOR CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain; Swelling/ Edema; Synovitis

  MAUDE report 15346924 ↗
• InjurySep 1, 2022Unstable; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY LEGAL, THAT THIS FEMALE PATIENT'S LEFT KNEE WAS REVISED 5 YEARS POST OP INITIAL TKA. REASON FOR THE REVISION WAS NOT REPORTED. NO ADDITIONAL INFORMATION.

  Patient problems: Aseptic loosening; Failure of Implant; Joint Laxity; Pain; Synovitis

  MAUDE report 15341082 ↗
• InjuryAug 12, 2022Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT A PATIENT WHO HAD UNDERWENT A PARTIAL KNEE REVISION ON (B)(6) 2018 IN WHICH AN OPTETRAK LOGIC PSC TIBIAL INSERT WAS IMPLANTED, UNDERWENT A SECOND REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 3 YEARS 5 MONTHS POST THE 2018 REVISION. UPON INFORMATION AND BELIEF, PLAINTIFF REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, INSTABILITY AND/OR COMPONENT LOOSENING.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 15220898 ↗
• InjuryJan 30, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY TWO YEARS POST INITIAL RIGHT TKA, THIS FEMALE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 13390235 ↗
• InjuryJan 27, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY EIGHT YEARS POST INITIAL RIGHT TKA, THIS FEMALE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 13370406 ↗
• InjuryDec 15, 2020Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A LEFT KNEE REVISION SURGERY ON (B)(6) 2017, DUE TO INSTABILITY. INITIAL SURGERY DATE WAS (B)(6) 2015. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 11009261 ↗
• InjuryAug 11, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2016, A (B)(6) Y/O, FEMALE PATIENT WITH A BMI OF 25.7, UNDERWENT IMPLANTATION OF A INSERT TIB 2 13MM KNEE POST STAB CNSTRN MOD NET CMPR MLD. ON (B)(6) 2018, APPROXIMATELY 23 MONTHS POST IMPLANT, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING.

  Patient problems: Failure of Implant

  MAUDE report 10394360 ↗