Optetrak Logic 02-012-35-3011Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 10885862001818), received between Aug 7, 2020 and Aug 4, 2026 — classified as 78 injuries.

The most frequently reported specific device problem is “Naturally Worn” (52 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K033883); 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 78 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Naturally Worn

  It was reported that this patient underwent a right knee replacement. Subsequently, the patient reported pain. The tibial insert and patellar component are subject to the recall. Evaluation also identified a loose femoral component. The patient was last known to be in stable condition following the event. No further information is available.

  Patient problems: Pain

  MAUDE report 50127209 ↗
• InjuryApr 16, 2026Naturally Worn

  ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. PER THE LEGAL FORM THE PATIENT WILL REQUIRE A REVISION DUE TO PROSTHESIS WEAR. BECAUSE THE PATIENT HAS FILED A LONG FORM, IT APPEARS THAT THEY ARE ALLEGING PROSTHESIS WEAR OF THEIR EXACTECH DEVICE. THE PATIENT IS LIMITED IN THEIR ACTIVITIES OF DAILY LIVING, AND REQUIRES ADDITIONAL PHYSICAL THERAPY.

  Patient problems: Insufficient Information

  MAUDE report 24905305 ↗
• InjuryJan 22, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED ASEPTIC LOOSENING, PAIN AND DISCOMFORT. AS A RESULT, THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 3 YEARS AND 7 MONTHS AFTER IMPLANTATION. DURING THE REVISION SURGERY THE TIBIAL INSERT WAS NOTED TO BE WORN. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Aseptic loosening; Discomfort; Pain

  MAUDE report 24145234 ↗
• InjuryOct 29, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A PATIENT WHO HAD A RIGHT TOTAL KNEE ARTHROPLASTY, UNDERWENT A REVISION PROCEDURE, APPROXIMATELY 11 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT HAD SEPSIS OF THE RIGHT KNEE. A WASHOUT AND POLY SWAP OF THE SAME SIZE IMPLANT WAS PERFORMED BY THE SURGEON. THERE WAS NO DEVICE BREAKAGE OR SURGICAL DELAY DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN AS THE HOSPITAL WON¿T RELEASE THE DEVICE. A DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Sepsis

  MAUDE report 23418254 ↗
• InjuryApr 18, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED. SUBSEQUENTLY, THE PATIENT STATED THAT THEY EXPERIENCED INFECTION, INSTABILITY WITH WALKING, AND SWELLING ON BOTH KNEES AFTER HER SURGERY.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Swelling/ Edema; Unspecified Infection

  MAUDE report 21865459 ↗
• InjuryFeb 26, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 61 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND INSTABILITY. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED ASEPTIC LOOSENING TIBIAL COMPONENT AND OSTEOLYSIS. INTRAOPERATIVELY THE SURGEON OBSERVED SIGNIFICANT SYNOVITIS AND WEAR OF THE LINER. THE FEMORAL COMPONENT WAS NOTED TO BE FIXED BUT EASILY REMOVED AND WITH SIGNIFICANT FIBROUS TISSUE AND OSTEOLYSIS LATERALLY. IT WAS NOTED THERE WAS NO EVIDENCE OF INFECTION. THE PATELLA WAS NOTED TO BE WELL FIXED BUT WITH SOME WEAR AND WITH SOME OSTEOLYSIS. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Distress; Implant Pain; Joint Laxity; Osteolysis; Synovitis

  MAUDE report 21468171 ↗
• InjuryFeb 4, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 75 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, AMBULATION DIFFICULTIES, INFLAMMATION, DISCOMFORT, FAILURE OF IMPLANT, JOINT EFFUSION, SCAR TISSUE, AND SYNOVITIS. 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; Failure of Implant; Inflammation; Joint effusion; Scar Tissue; Synovitis

  MAUDE report 21305770 ↗
• InjuryJan 30, 2025Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THIS PATIENT'S INITIAL KNEE PROCEDURE WAS (B)(6) 2021. PATIENT STATED THAT THEY ARE SUFFERING PAIN AND SQUEAKING NOISES ON HER KNEE IMPLANT. IT WAS ALSO NOTED BY THE PATIENT THAT THEY UNDERWENT KNEE REPLACEMENT AS SURGICAL TREATMENT. IT IS UNKNOWN IF THEY INTENDED TO INDICATE THE INITIAL PROCEDURE OR IF THEY UNDERWENT A REVISION PROCEDURE. PARTIAL EBI DATA LOCATED BASED ON INFORMATION PROVIDED. BASED ON SURGERY DATE IN EBI THE INITIAL PROCEDURE DATE MAY HAVE BEEN ENTERED INCORRECTLY (2012 VS 2021). "INITIAL" SURGERY MAY HAVE BEEN PERFORMED ON (B)(6) 2012. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 21276659 ↗
• InjuryJan 27, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 10 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR AND PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 21246281 ↗
• InjuryJan 27, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  *ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 31JUL2023* AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON 15 NOV 2010. THE PATIENT BEGAN EXPERIENCING INCREASING PAIN, ¿SHIFTING OF HER KNEES,¿ AND IMPAIRED MOBILITY. RECURRENT EFFUSIONS AND INCREASING PAIN ALSO BEGAN OCCURRING. X-RAYS DEMONSTRATED EVIDENCE OF FEMORAL OSTEOLYSIS. THE SURGEON DIAGNOSED THE PATIENT WITH FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO POLYETHYLENE WEAR, OSTEOLYSIS, AND FEMORAL LOOSENING, AND REVISION SURGERY WAS RECOMMENDED. PATIENT UNDERWENT A LEFT KNEE REVISION SURGERY, APPROXIMATELY 12 YEARS 6 MONTHS POST PRIMARY PROCEDURE. DURING THE REVISION SURGERY, THE ORTHOPEDIC SURGEON FOUND POLYETHYLENE DEBRIS IN THE SYNOVIAL TISSUE AND OSTEOLYSIS OF THE LEFT TIBIA. ¿SIGNIFICANT UNCONTAINED OSTEOLYSIS IN THE POSTERIOR MEDIAL AND POSTEROLATERAL CONDYLES¿ OF THE FEMUR WAS ALSO NOTED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. NO ADDITIONAL INFORMATION IS AVAILABLE. *ORIGINAL DESCRIPTION SUMMARY* AS REPORTED, APPROXIMATELY 12.6 YEARS POST INITIAL LEFT TKA, THE PATIENT COMPLAINT OF PAIN. PATIENT HAD A REVISION DUE TO LOOSE FEMU

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

  MAUDE report 21240855 ↗
• InjuryDec 12, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 136 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, PAIN AND FAILURE OF IMPLANT. INITIAL SURGERY AND 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; Pain

  MAUDE report 20916576 ↗
• InjuryOct 30, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 78 YO FEMALE PATIENT WHO HAD AN INITIAL RIGHT KNEE IMPLANTED IN (B)(6) 2013 AND WAS REVISED IN (B)(6) 2022, UNDERWENT A SECOND REVISION IN (B)(6) 2024, APPROXIMATELY 2 YEARS 3 MONTHS POST THE (B)(6) 2022 REVISION. POLY EXCHANGE DUE TO THE PATELLA WAS LOOSE AND WORN. INSERT WAS SHOWING SIGNS OF WEAR. THE PATELLA AND INSERT WERE REPLACED WITH A COMPETITOR¿S DEVICES. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISCARDED. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 20571384 ↗
• InjuryOct 24, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA. CASE-(B)(4) RK IS ASSOCIATED WITH THIS CASE. WHILE REVIEWING CASE-(B)(4) DOCUMENTING THE REVISION OF THE RIGHT KNEE, IT WAS DISCOVERED THAT THE ORIGINAL EMAIL ALSO LISTED THE DEVICE INFORMATION FOR THE UNREVISED LEFT KNEE. NO ALLEGATIONS WERE MADE AGAINST THIS DEVICE IN THE EMAIL. AT THE TIME OF LEGAL NOTIFICATION, A REVISION PROCEDURE HAD NOT BEEN PERFORMED. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022.

  Patient problems: Insufficient Information

  MAUDE report 20526470 ↗
• InjuryOct 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 125 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. PATIENT IS CURRENTLY SUFFERING FROM THE FOLLOWING COMPLICATIONS, INJURIES AND/OR INDICATIONS, SOME OR ALL OF WHICH MADE REVISIONS MEDICALLY NECESSARY; PAIN, DISCOMFORT, AND DIFFICULTY WALKING AS A RESULT OF THE DEFECTIVE NATURE OF THE EXACTECH KNEE REPLACEMENT SYSTEM. PLAINTIFF HAS SUFFERED AND MAY CONTINUE TO SUFFER SEVERE AND PERMANENT PERSONAL INJURIES INCLUDING POLYETHYLENE WEAR AND DEVICE FAILURE, DISBURSEMENT OF POLYETHYLENE LINER INTO BONE AND OTHER BODILY STRUCTURES, PAINFUL KNEE REVISION SURGERIES TO REMOVE OR REVISE THE DEFECTIVE DEVICE, CONTINUED REHABILITATION, MEDICAL CARE AND POSSIBLY ADDITIONAL SURGERIES. 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; Pain

  MAUDE report 20505894 ↗
• InjurySep 17, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA . IT WAS REPORTED THAT APPROXIMATELY UNKNOWN MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, RECURRENT SWELLING, PERSISTENT DISCOMFORT, OSTEOLYSIS. 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: Discomfort; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20241087 ↗
• InjurySep 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 130 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20135601 ↗
• InjurySep 4, 2024Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Lack of Effect; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Lack of Effect

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 53 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING. PLAINTIFF HAS SUFFERED THE FOLLOWING INJURIES: JOINT PAIN, JOINT SWELLING, JOINT STIFFNESS, LIMITED RANGE OF MOTION, LOSS OF MOBILITY, MUSCLE TISSUE DAMAGE, TISSUE DAMAGE, DEVICE FAILURE NECESSITATION, AND PAINFUL REVISION SURGERY. PLAINTIFF CONTINUES TO BE LIMITED IN HER ACTIVITIES OF DAILY LIVING, EXPERIENCES DAILY PAIN AND DISCOMFORT IN HER RIGHT KNEE WHICH IMPACTS HER QUALITY OF LIFE. PLAINTIFF SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE; REHABILITATION; HOME HEALTH CARE; LOSS OF EARNING CAPACITY; MENTAL AND EMOTIONAL DISTRESS; LOSS OF CONSORTIUM AND PAIN AND SUFFERING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Implant Pain; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20134674 ↗
• InjuryAug 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 57 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: Insufficient Information

  MAUDE report 20028774 ↗
• InjuryAug 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 98 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20004191 ↗
• InjuryJul 25, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 45 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE FOR UNKNOWN ISSUES. THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOGRAPHS OR X-RAYS WERE PROVIDED FOR REVIEW; THEREFORE THE REPORTED EVENT CANNOT BE CONFIRMED THROUGH ANALYSIS. NO OPERATIVE NOTES WERE PROVIDED; THEREFORE, A REVIEW OF DEVICE USAGE AND TECHNIQUE COULD NOT BE PERFORMED. NO INFORMATION CONCERNING PATIENT CONDITIONS, CO-MORBIDITIES, OR OTHER HEALTH OR ANATOMICAL CONCERNS WAS PROVIDED AND IT IS THEREFORE UNKNOWN IF PATIENT-RELATED FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED BASED ON THE INFORMATION MADE AVAILABLE. SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

  Patient problems: Insufficient Information

  MAUDE report 19828551 ↗
• InjuryJul 17, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 95 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19760920 ↗
• InjuryJul 9, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 102 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, SYNOVITIS, DELAMINATION OF THE POLYETHYLENE, POLYETHYLENE WEAR, INSTABILITY, LOSS OF MOBILITY, SWELLING, PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Angioedema; Ankylosis; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Aseptic loosening; Implant Pain; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19701735 ↗
• InjuryMay 23, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT KNEE ARTHROPLASTY ON (B)(6) 2016, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2017, APPROXIMATELY 8 MONTHS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19386215 ↗
• InjuryApr 26, 2024Mechanical Problem; Unstable; Naturally Worn; Mechanical Problem; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD A LEFT TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2013 AND THEN WAS REVISED ON (B)(6) 2023. THE PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO SIGNIFICANT PAIN IN HER LEFT KNEE, ALONG WITH SWELLING, INSTABILITY, LIMITED RANGE OF MOTION, AND LOSS OF MOBILITY. THE MOSTLY LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED.

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

  MAUDE report 19191874 ↗
• InjuryApr 11, 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 REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 9 YEARS AND 8 MONTHS AFTER INITIAL IMPLANT AFTER OBSERVED "OBVIOUS BONE LOSS," IN THE X-RAY TAKEN AND A FOLLOW-UP CT SCAN DEMONSTRATED LARGE JOINT EFFUSION AND LIKELY SYNOVITIS CHANGES. . NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 19085968 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033883. One submission often covers many models, so check the product and lot details in each record.

• Z-0584-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
• Z-0906-2015 · Oct 9, 2014 · Terminated
  Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants