Optetrak Logic 02-012-35-4009Recalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 10885862001887), received between Aug 8, 2020 and Aug 18, 2026 — classified as 106 injuries.

The most frequently reported specific device problem is “Naturally Worn” (86 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. 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 25 most recent of 106 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Naturally Worn

  It was reported via legal notification that a patient underwent initial left total knee arthroplasty. The patient alleges having sustained injuries because of the recalled product have resulted in ongoing treatment. There is no other patient demographic or medical history available. Further patient impact is unknown. No additional information is available.

  Patient problems: Insufficient Information

  MAUDE report 50302279 ↗
• InjuryMay 12, 2026Naturally Worn

  AS REPORTED, THE PATIENT RECEIVED A BILATERAL TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 8 YEARS AFTER THE INDEX SURGERY, THE PATIENT¿S RIGHT KNEE WAS REVISED DUE TO REPORTED PAIN, FEMORAL LOOSENING, AND POLYETHYLENE WEAR. PER THE OPERATIVE NOTES, THE PATIENT HAS INCREASING PAIN AND RECURRENT EFFUSIONS WITH X-RAY EVIDENCE OF OSTEOLYSIS BEHIND THE FEMORAL COMPONENT. THE SURGEON ELECTED TO REVISE THE PATIENT WITH A CC FEMORAL COMPONENT, A FEMORAL CONE, ONE POSTERIOR AUGMENT BLOCK, TWO DISTAL FEMORAL AUGMENT BLOCKS, A STEM EXTENSION, AND A PS TIBIAL INSERT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE REVISION SURGERY.

  Patient problems: Aseptic loosening; Joint effusion; Osteolysis; Pain

  MAUDE report 25153018 ↗
• InjuryNov 17, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TKA (TOTAL KNEE ARTHROPLASTY) ON THE LEFT SIDE. APPROXIMATELY 9 YEARS POST INITIAL OPERATION, THEY NEEDED A SYNOVECTOMY AND A REVISION OF THE PATELLA AND TIBIAL INSERT. THE PATELLA EXHIBITED WEAR ALONG THE LATERAL AND MEDIAL TRACKING PATH WHILE THE TIBIAL INSERT HAD WEAR ON POSTEROLATERAL CORNER OF THE LATERAL COMPARTMENT. THE FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED AND NOT REVISED.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 23570315 ↗
• InjuryApr 17, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED APPROXIMATELY 86 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT SURGERY; A MALE PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE TO ADDRESS PAIN AND SYMPTOMS OF INSTABILITY. A REVISION OPERATIVE REPORT WAS PROVIDED. OPERATIVE FINDINGS NOTED THE PATELLA COMPONENT WAS WELL FIXED, FEMORAL COMPONENT LOOSE AND DE-BONDED FROM THE CEMENT AND THE TIBIAL WELL FIXED. IT WAS NOTED THE POLYETHYLENE INSERT SHOWED EVIDENCE OF WEAR OF THE MEDIAL TIBIAL TRAY. INFECTIOUS WORKUP WAS PERFORMED; INFLAMMATORY MARKERS WERE NEGATIVE. THE PATIENT WAS REVISED TO A COMPETITOR'S CONSTRUCT. THE PATIENT WAS NOTED TO BE IN STABLE CONDITION FOLLOWING THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis; Unspecified Tissue Injury

  MAUDE report 21859019 ↗
• InjuryFeb 18, 2025Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 91 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION SURGERY TO ADDRESS PROSTHESIS WEAR AND LOOSENING. A REVISION OPERATIVE REPORT WAS PROVIDED. POST OPERATIVE DIAGNOSIS NOTED ASEPTIC LOOSENING AND SIGNIFICANT POLYETHYLENE WEAR, LEFT KNEE. INTRAOPERATIVELY THE SURGEON OBSERVED SYNOVITIS, OSTEOLYSIS AND NOTED THE POLYETHYLENE HAD EVIDENCE OF WEAR AND DELAMINATION. THE FEMORAL COMPONENT WAS NOTED TO BE SIGNIFICANTLY LOOSE AND DEBONED FROM UNDERLYING CEMENT. POST OPERATIVE NOTES INDICATED AN UNINFECTED OPERATIVE WOUND IN WHICH NO INFLAMMATION WAS ENCOUNTERED. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 21401839 ↗
• InjuryJan 17, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 144 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, DISCOMFORT, JOINT LAXITY, PAIN, OSTEOLYSIS, 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Joint Laxity; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 21181058 ↗
• InjuryJan 8, 2025Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY DUE TO GONARTHROSIS. THE PATIENT REPORTED THE ONSET OF PAINFUL SYMPTOMS WITH GONALGIA AND ASSOCIATED FUNCTIONAL LIMITATION, FOR WHICH THEY PRESENTED TO THE EMERGENCY ROOM. ON THIS OCCASION X-RAYS WERE TAKEN THAT SHOWED SIGNS OF PROSTHETIC MOBILIZATION. SAMPLES WERE TAKEN FOR CULTURE TESTS AND A CHEMICAL-PHYSICAL EXAMINATION, AND THE PATIENT WAS PLACED ON THE WAITING LIST FOR A TWO-STAGE SURGICAL REVISION. UPON ADMISSION FOR PROSTHETIC REMOVAL, NEW X-RAYS CONFIRMED THE MOBILIZATION. APPROXIMATELY SIX YEARS POST THE INITIAL TOTAL KNEE ARTHROPLASTY, AND FIVE DAYS AFTER THE PATIENT VISIT TO THE EMERGENCY ROOM, THE PATIENT UNDERWENT SURGERY FOR THE EXPLANTATION OF THE KNEE PROSTHESIS AND THE PLACEMENT OF AN ARTICULATED CEMENTED SPACER. DURING THE SURGERY, SAMPLES WERE TAKEN FOR CULTURE TESTS, WHICH RETURNED NEGATIVE RESULTS; THE PROSTHETIC COMPONENTS WERE SENT FOR SONICATION AND CULTURE EXAMINATION. INTRAOPERATIVELY, THERE WAS A CLEAR MOBILIZATION OF THE FEMORAL COMPONENT AND A SIGNIFICANT VILLOUS SYNOVIAL INFILTRATE. AN ARTICULATED CEMENTED SPACER WAS IMPLANTED, AND THE PATIENT IS CURRENTLY AWAITING SURGERY FOR

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

  MAUDE report 21102007 ↗
• InjuryJan 7, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 69 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS ASEPTIC LOOSENING OF THE FEMORAL COMPONENT, OSTEOLYSIS, PAIN, AND INSTABILITY. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POSTOPERATIVE DIAGNOSIS INDICATED ASEPTIC LOOSENING OF THE FEMORAL COMPONENT, SYNOVITIS, AND OSTEOLYSIS SECONDARY TO POLYETHYLENE WEAR OF THE TIBIAL AND PATELLAR COMPONENTS. TISSUE SPECIMENS SENT TO PATHOLOGY REVEALED EVIDENCE OF POLYETHYLENE PARTICULATE DEBRIS, INCLUDING SMALL AND LARGE POLYETHYLENE PARTICLES RESULTING IN TISSUE REACTION TO PARTICULATE IMPLANT MATERIAL AND TISSUE NECROSIS. SURGEON PERFORMED A REVISION TOTAL KNEE REPLACEMENT. 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; Implant Pain; Joint Laxity; Osteolysis; Synovitis

  MAUDE report 21096776 ↗
• InjuryOct 25, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 67 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, INSTABILITY, SCARRING, EFFUSION. 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; Joint Laxity; Joint effusion; Pain; Swelling/ Edema

  MAUDE report 20532066 ↗
• InjuryOct 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 100 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. THERE IS NO REPORT OF A PLANNED OR SCHEDULED REVISION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 20505403 ↗
• InjuryOct 21, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044) CASE-(B)(4) RK REV CASE-(B)(4) RK CURRENT IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 100 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. PLAINTIFF WAS REQUIRED TO UNDERGO A REVISION SURGERY TO REMOVE THE DEFECTIVE DEVICE. PLAINTIFF DOES NOT RECALL EXACT DATE, BUT DISCOVERY AND INVESTIGATION CONTINUE. ADDITIONALLY, PLAINTIFF HAS SUFFERED THE FOLLOWING INJURIES INCLUDING BUT NOT LIMITED TO REHABILITATION, PAIN AND DISCOMFORT, SWELLING, POOR BALANCE, WHICH ALL REQUIRE MEDICAL CARE, REHABILITATION, HOME HEALTH CARE, MENTAL AND EMOTIONAL DISTRESS AND PAIN AND SUFFERING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022.

  Patient problems: Balance Problems; Discomfort; Emotional Changes; Pain; Swelling/ Edema

  MAUDE report 20500592 ↗
• InjurySep 20, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 129 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. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022.

  Patient problems: Discomfort; Emotional Changes; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20272685 ↗
• InjurySep 11, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 126 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Insufficient Information; Osteolysis

  MAUDE report 20192846 ↗
• InjurySep 11, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA PATIENT ID: (B)(6). IMPLANT DATE: (B)(6) 2012, DR. (B)(6) EXPLANT DATE: (B)(6) 2023, DR. (B)(6), OP REPORT ATTACHED REVISION OP REPORT POSTOPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE REPLACEMENT DUE TO POLY WEAR ISSUES WITH OSTEOLYSIS. S. THE FEMORAL COMPONENT WAS SLIGHTLY LOOSE BUT THE SURGEON WAS ABLE TO REMOVE THE FEMORAL IMPLANT WITH VERY MINIMAL BONE LOSS. THERE WAS MASSIVE WEAR OFF OF THE POSTERIOR LIPS BOTH MEDIALLY AND LATERALLY ON THE POLYETHYLENE INSERT. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. UNABLE TO LOCATE SURGEON/PATIENT IN EBI. SERIAL NUMBER PROVIDED. HISTORICAL RECORD AND SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. NO FURTHER INFORMATION. (B)(6) 02-012-35-4009 - LOGIC TIBIA PS MOD INSRT ***SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K033883.

  Patient problems: Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 20192703 ↗
• InjurySep 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 60 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED LOOSENING. 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: Pain; Swelling/ Edema; Synovitis

  MAUDE report 20168905 ↗
• InjuryAug 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 161 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 20033126 ↗
• InjuryAug 22, 2024Naturally Worn; Naturally Worn

  LEGAL CASE - USA (B)(6) IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 97 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 20023971 ↗
• InjuryAug 15, 2024Naturally Worn; Naturally Worn

  LEGAL CASE - USA IT WAS REPORTED THAT APPROXIMATELY 19 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: Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 19994098 ↗
• InjuryAug 6, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 153 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, AND POPITEAL CYST. 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: Cyst(s); Synovitis

  MAUDE report 19922505 ↗
• InjuryAug 5, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 153 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS, 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: Joint Laxity; Osteolysis

  MAUDE report 19914468 ↗
• InjuryJul 30, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 119 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SIGNIFICANT POLY WEAR, LOOSENING OF THE FEMUR. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Synovitis

  MAUDE report 19860135 ↗
• InjuryJul 17, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 60 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, RIGHT KNEE PAIN, SWELLING OF RIGHT KNEE, SWOLLEN KNEE WITH COMPLICATION OF INTERNAL PROSTHETIC DEVICE AND POSTERIOR INSTABILITY OF RIGHT KNEE. 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: Implant Pain; Joint Laxity; Swelling/ Edema

  MAUDE report 19763649 ↗
• InjuryJul 16, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 155 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, INSTABILITY AND SYNOVITIS. 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: Cyst(s); Discomfort; Failure of Implant; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 19752297 ↗
• InjuryJul 15, 2024Naturally Worn; Naturally Worn

  APPROXIMATELY 5.5 YEARS AFTER A TOTAL RIGHT KNEE REPLACEMENT, THE PATIENT WAS REVISED DUE TO SUSPECTED EARLY POLY WEAR. THE PATIENT WAS REVISED TO AN ACTIVE-E POLY. THE EVENT IS NOT RELATED TO A BREAKAGE OF THE DEVICE. THE EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19740950 ↗
• InjuryJul 10, 2024Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  LEGAL CASE ¿ USA PATIENT ID: (B)(6) + LEFT KNEE. IT WAS REPORTED THAT APPROXIMATELY 119 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE WITH DR. (B)(6) MD, AT (B)(6) IN (B)(6), TO ADDRESS CLINICAL AND RADIOGRAPHIC SIGNS OF PREMATURE POLYETHYLENE WEAR. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PREOPERATIVE AND POSTOPERATIVE DIAGNOSES INDICATED FAILED LEFT TOTAL KNEE TIBIAL POLYETHYLENE DUE TO PREMATURE POLY WEAR AND POLY RECALL. OPERATIVE FINDINGS INDICATED THERE WAS FOUND TO BE A CLEAN WOUND WITH CLEAR SYNOVIAL JOINT FLUID. THERE WERE WELL-FIXED FEMORAL, TIBIAL, AND PATELLAR COMPONENTS WITH NO OSTEOLYSIS. THERE WAS A VISIBLE AMOUNT AND PALPABLE AMOUNT OF POLYETHYLENE WEAR WITHIN THE WEIGHTBEARING PORTIONS OF THE TIBIAL POLYETHYLENE. THERE WAS ENCAPSULATED POLYETHYLENE DEBRIS WITHIN THE SYNOVIUM WITH A SECONDARY THICKENED SYNOVIUM AND A COMPLETE SYNOVECTOMY WAS PERFORMED. ATTENTION WAS THEN TURNED TO THE TIBIAL POLYETHYLENE INSERT, WHICH WAS DISLODGED FROM THE TIBIAL COMPONENT. A TRIAL REDUCTION WITH A 10MM INSERT WAS TRIALED. THE KNEE WAS TAKEN INTO FULL EXTENSION WITH EXCELLENT RANGE OF MOTION TO 130 DEGREES WITH GOOD PATELLAR

  Patient problems: Insufficient Information; Synovitis

  MAUDE report 19711474 ↗

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