Optetrak Logic 02-012-44-2513Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885862173539), received between Aug 10, 2020 and Jun 24, 2024 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 82 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR AND MAY REQUIRE FUTURE REVISION SURGERY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19600809 ↗
• InjuryJun 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 67 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN AND DISCOMFORT, LIMITED ACTIVITIES OF DAILY LIVING, IMPACTED QUALITY OF LIFE; DEBILITATING INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, PAIN AND DISCOMFORT; SWELLING; GAIT IMPAIRMENT; POOR BALANCE; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; BONE DAMAGE; AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE; FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO COST OF MEDICAL CARE; REHABILITATION; HOME HEALTH CARE; LOSS OF EARNING CAPACITY; MENTAL AND EMOTIONAL DISTRESS; AND PAIN AND SUFFERING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. CASES, (B)(4) IS ASSOCIATED WITH THIS CASE.

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

  MAUDE report 19483263 ↗
• InjuryMay 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 45 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR PAIN, STIFFNESS, SWELLING, 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; Pain; Swelling/ Edema

  MAUDE report 19299393 ↗
• InjuryMar 21, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 8 YEARS 7 MONTHS AFTER INITIAL IMPLANT. THERE IS NO DEVICE INFORMATION PROVIDED. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 18951288 ↗
• InjuryOct 18, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2019. APPROXIMATELY 4 YEARS AND 4 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. 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) 2023 DIAGNOSIS: LEFT KNEE SYNOVITIS AND POLYETHYLENE WEAR THE PATIENT WAS NOTED TO HAVE SIGNIFICANT EFFUSION. SHE HAD SIGNIFICANT SYNOVITIS ASSOCIATED WITH POLYETHYLENE WEAR. THE POLYETHYLENE WAS REMOVED. IT WAS NOTED TO HAVE PITTING AND DELAMINATION PARTICULARLY IN THE MEDIAL COMPARTMENT AND POST. THERE WERE MULTIPLE FLAKES ON THE POLYETHYLENE INSERT IN THE JOINT. THESE WERE REMOVED. THERE WAS NO EVIDENCE OF ANY LYSIS OR LOOSENING OF EITHER THE FEMORAL OR TIBIAL COMPONENTS. THESE WERE LEFT ALONE. THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. AS DIRECTED BY QA MANAGEMENT: THIS LEGAL COMPLAINT FOR POLYETHYLENE ISSUES OCCURRED IN THE US. THE EVENT DID NOT OCCUR IN, NOR IS IT REPORTABLE FOR AUSTRALIA, BRAZIL, CANADA, EEA/EU,

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

  MAUDE report 17957131 ↗
• InjuryOct 3, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2019 WITH A SECOND OPTOTRAK LOGIC POLYETHYLENE TIBIAL INSERT (SERIAL #: (B)(6). THIS DEVICE HAS NOT BEEN EXPLANTED. THE PATIENT HAS SUFFERED AND CONTINUES TO SUFFER INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; AND BONE LOSS. 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Insufficient Information; Pain

  MAUDE report 17859325 ↗
• InjuryMay 15, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT TKA (B)(6) 2015 DUE TO SEVERE OSTEOARTHRITIS. THEY UNDERWENT LEFT KNEE REVISION (B)(6) 2022, APPROXIMATELY 6 YEARS10 MONTHS AFTER THEIR INITIAL PROCEDURE. POSTOPERATIVE DIAGNOSIS: IMPLANT WEAR WITH OSTEOLYSIS, AND LOOSENING. THE SURGEON NOTED THAT THE PATIENT HAD A LARGE AMOUNT OF FOREIGN BODY REACTION TISSUE THROUGHOUT THE ENTIRE KNEE JOINT. THERE WAS LOOSENING OF THE FEMORAL COMPONENT, AND THE INSERT WAS NOTED TO HAVE A FAIR AMOUNT OF WEAR. ACCORDING TO THE SURGEON, "A GOOD DEAL OF FOREIGN BODY REACTION TISSUE HAD OCCURRED WITH EROSION OF BONE, PARTICULARLY ON THE POSTERIOR SECTION OF THE FEMORAL COMPONENT, WHICH ALLOWED THE COMPONENT TO WORK LOOSE." 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; Osteolysis; Synovitis

  MAUDE report 16934758 ↗
• InjuryApr 19, 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 (B)(6) 2016. THE PATIENT EXPERIENCED PROGRESSIVE PAIN SINCE FALL 2021, INTERMITTENT SWELLING AND INSTABILITY. THE PATIENT WAS REVISED TO A TRULIANT TIBIAL IMPLANT PSC INSERT SIZE 2.5, 12MM 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.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 16773877 ↗
• InjuryFeb 28, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT A PATIENT, INITIAL LEFT TOTAL KNEE REPLACEMENT, IMPLANTED WITH A TRULIANT DEVICE ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 2 YEARS 6 MONTHS POST THE INITIAL PROCEDURE, FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, INSTABILITY, AND/OR COMPONENT LOOSENING. THE PLAINTIFF EXPERIENCES DAILY PAIN AND DISCOMFORT IN HER LEFT KNEE WHICH LIMITS HER ACTIVITIES OF DAILY LIVING AND IMPACTS HER QUALITY OF LIFE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Insufficient Information; Joint effusion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 16454100 ↗
• InjuryJan 19, 2023Naturally Worn; Naturally Worn

  AS REPORTED BY THE LEGAL DEPARTMENT, APPROXIMATELY 8 YEARS POST OP THE INITIAL TKA, THIS 69 Y/O FEMALE PATIENT WAS REVISED DUE TO POLYETHYLENE WEAR AND PERIPROSTHETIC OSTEOLYSIS OF THE RIGHT KNEE JOINT.

  Patient problems: Cyst(s); Failure of Implant; Joint effusion; Osteolysis; Scar Tissue; Synovitis

  MAUDE report 16207245 ↗
• InjuryAug 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, A (B)(6) Y/O, FEMALE PATIENT WITH A BMI OF 18.8, UNDERWENT IMPLANTATION OF A INSERT TIB 2.5 13MM KNEE POSTSTAB CNSTRN MOD NET CMPR MLD. ON (B)(6) 2018, APPROXIMATELY 6 MONTHS POST IMPLANT, THE PATIENT UNDERWENT REVISION DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10388823 ↗