Optetrak Logic 02-012-35-4013Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10885862001900), received between Oct 18, 2019 and Mar 4, 2026 — classified as 46 injuries.

The most frequently reported specific device problem is “Naturally Worn” (38 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 46 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  REPORT #2 OF 2 FOR THIS EVENT. IT WAS REPORTED VIA LEGAL DOCUMENTATION A PATIENT HAD INITIAL BILATERAL TOTAL KNEE ARTHROPLASTIES. SUBSEQUENTLY, 9 YEARS LATER, THE PATIENT REPORTED BEING ADVISED THAT A TOTAL RIGHT KNEE REVISION SURGERY IS REQUIRED DUE TO PROSTHESIS WEAR. IT IS UNKNOWN IF THE PATIENT UNDERWENT A REVISION PROCEDURE OR PLANNED A REVISION PROCEDURE. THE PATIENT ALLEGES EXPERIENCING PAIN, DISCOMFORT, AMBULATORY DIFFICULTIES, BALANCE ISSUES AND SOFT TISSUE DAMAGE AND COMPONENT PART LOOSENING. NO CLINICAL INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Aseptic loosening; Balance Problems; Discomfort; Osteolysis; Pain; Unspecified Tissue Injury

  MAUDE report 24507678 ↗
• InjuryApr 3, 2025Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION APPROXIMATELY MONTHS AFTER A RIGHT KNEE REPLACEMENT SURGERY. THE PATIENT UNDERWENT A REVISION SURGERY TO ADDRESS PROSTHESIS WEAR AND PAIN. FEMUR AND PATELLA COMPONENTS WERE INDICATED TO BE LOOSE. NO SURGICAL OR MEDICAL INTERVENTIONS WERE RECORDED. ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 21767440 ↗
• InjuryMar 14, 2025Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 81 MONTHS AFTER A LEFT TOTAL KNEE PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING WITH CHRONIC FRACTURE OF THE PATELLAR COMPONENT, AND SUSPICION OF LOOSENING FEMORAL COMPONENT THE PATIENT DEVELOPED DISABLING PAIN APPROXIMATELY 24 MONTHS POST PRIMARY PROCEDURE. FINDINGS INDICATED SIGNIFICANT SYNOVITIS, OSTEOLYSIS OF BOTH MEDIAL LATERAL FEMORAL CONDYLES AND MEDIAL TIBIAL PLATEAU, AND GROSSLY LOOSE PATELLA WITH CHRONIC FRACTURE. THE SURGEON PERFORMED A REVISION LEFT TOTAL KNEE REPLACEMENT OF ALL COMPONENTS USING A COMPETITOR¿S DEVICES. NO OTHER ISSUES OR COMPLICATIONS WERE REPORTED. THE PATIENT WAS AWOKEN FROM ANESTHESIA AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Joint effusion; Muscle Weakness/Atrophy; Osteolysis; Pain; Synovitis

  MAUDE report 21609083 ↗
• InjuryFeb 19, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 11 YEARS AFTER INITIAL IMPLANT.

  Patient problems: Joint effusion; Pain; Scar Tissue; Synovitis

  MAUDE report 21412123 ↗
• InjuryJan 21, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 7 YEARS POST OP INITIAL LEFT TKA, THIS 61 Y/O MALE PATIENT WAS REVISED DUE TO LOOSE FEMUR AND RECALL OF THE TIBIAL INSERT. SURGEON REVISED TO A CONSTRAINED SIZE FOR FEMUR WITH EXTENSION, STEM AND FEMORAL AUGMENTS. ALSO A FEMORAL CONE & CC TIBIAL INSERT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS AND IMAGES ATTACHED. NO PRODUCT RETURN; LAWYER.

  Patient problems: Insufficient Information

  MAUDE report 21197505 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT, WHO HAD AN INITIAL LEFT KNEE IMPLANTED IN (B)(6) 2015, AND WAS REVISED IN (B)(6) 2018, UNDERWENT A SECOND REVISION IN (B)(6) 2024, APPROXIMATELY 6 YEARS 6 MONTHS POST THE 2018 REVISION. THE PATIENT WAS SUFFERING FROM LAXITY, INSTABILITY, PAIN, SYNOVITIS WITH EFFUSION. THE PE WAS CHANGED. THE IMPLANT WAS NON EVOH, IMPLANTED AFTER 5 YEARS. THE EXPLANTED DEVICES ARE NOT RETURNING. NO FURTHER INFORMATION.

  Patient problems: Joint Laxity; Joint effusion; Pain; Synovitis

  MAUDE report 20570667 ↗
• InjuryOct 10, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA IT WAS REPORTED THAT APPROXIMATELY 105 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, EXTREMITY SWELLING, DISCOMFORT; SYNOVITIS, TUMOR-LIKE GROWTH, MILD POLY WEAR AND DELAMINATION ON THE TIBIAL INSERT, LOOSE/DEBONDING FEMORAL. 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. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022.

  Patient problems: Discomfort; Inadequate Osseointegration; Swelling/ Edema; Synovitis

  MAUDE report 20422151 ↗
• InjurySep 26, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 117 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS 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. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022.

  Patient problems: Insufficient Information; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20309184 ↗
• InjurySep 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 31 MONTHS AFTER A RIGHT 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: Insufficient Information

  MAUDE report 20179543 ↗
• InjuryJul 17, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 124 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR; REVISION SURGERY, REHABILITATION, PAIN AND SUFFERING, PAST COST OF MEDICAL CARE, FUTURE COST OF MEDICAL CARE, LOSS OF EARNING CAPACITY AND MENTAL AND EMOTIONAL DISTRESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Distress; Emotional Changes; Osteolysis; Pain

  MAUDE report 19760089 ↗
• InjuryJun 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK LOGIC DEVICE ON THE RIGHT KNEE AND THEN APPROXIMATELY 4 YEARS, 4 MONTHS LATER THE PATIENT WAS REVISED. IT IS STATED THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: PAIN, STIFFNESS, DISCOMFORT AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTED PLAINTIFF'S MOBILITY AND QUALITY OF LIFE. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 19606347 ↗
• InjuryMay 24, 2024Unstable; Detachment of Device or Device Component; Naturally Worn; Unstable; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 162 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, INSTABILITY, AND RECURRENT EFFUSIONS. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cyst(s); Failure of Implant; Implant Pain; Joint Laxity; Joint effusion; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 19395043 ↗
• InjuryMay 14, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, THE 56-YEAR-OLD MALE HAD A LEFT TKA ON (B)(6) 2013. THE PATIENT PRESENTED WITH INFLAMMATION / POLYETHYLENE WEAR WITHOUT EVIDENCE OF OSTEOLYSIS ON (B)(6) 2021 THE ACTION TAKEN IS OTHER - ARTHROSCOPIC SYNOVIAL BIOPSY OF RIGHT KNEE. THIS WAS A DAY CASE PROCEDURE, AND UPON REVIEW, WAS FOUND TO HAVE BEEN RECORDED AS INPATIENT HOSPITALIZATION. THIS IS NOW CONSIDERED AN AE, NOT AND SAE AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED ON (B)(6) 2021. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THIS EVENT IS RELATED TO (B)(4) AND WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Failure of Implant; Inflammation

  MAUDE report 19317015 ↗
• InjuryMay 14, 2024Naturally Worn; Naturally Worn

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, THE 72-YEAR-OLD PATIENT HAD A LEFT TKA ON (B)(6) 2016. THE PATIENT PRESENTED WITH POLYETHYLENE WEAR W/EVIDENCE OF OSTEOLYSIS ON (B)(6) 2021. THE PATIENT EXPERIENCED SWELLING IN LEFT KNEE, SURGEON REPORTS THIS IS DUE TO THE POLYETHYLENE WEAR WHICH IS VISIBLE ON THE X-RAY WITH EVIDENCE OF OSTEOLYSIS. NO ACTION WAS TAKEN AND THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND DEFINITELY NOT RELATED TO THE PROCEDURE. THIS EVENT REPORT IS RELATED TO (B)(6) AND WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Osteolysis

  MAUDE report 19316276 ↗
• InjuryMay 14, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 103 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND OSTEOLYSIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED AND CONFIRMED WEAR AND OSTEOLYSIS. COMPONENTS WERE FOUND TO BE WELL FIXED AND WERE REPLACED WITH A COMPETITOR PROSTHESIS. 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; Insufficient Information; Osteolysis

  MAUDE report 19313051 ↗
• InjuryApr 15, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 9 YEARS AND 2 MONTHS AFTER INITIAL IMPLANT. 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; Emotional Changes; Failure of Implant; Loss of Range of Motion; Pain

  MAUDE report 19103865 ↗
• InjuryApr 10, 2024Naturally Worn; Naturally Worn

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, THE 58-YEAR-OLD PATIENT HAD A LEFT TKA ON (B)(6) 2015. ON (B)(6) 2021, PATIENT PRESENTED POLYETHYLENE WEAR WITHOUT EVIDENCE OF OSTEOLYSIS. ON (B)(6) 2021, THE PATIENT UNDERWENT ARTHROSCOPY, BIOPSY AND DEBRIDEMENT OF RIGHT KNEE DUE TO PAIN AND PULLING, X-RAY SHOWS EXCESSIVE MEDIAL POLY WEAR THAT IS REPORTED ON (B)(4). THE PATIENT THEN UNDERWENT RIGHT TOTAL KNEE REPLACEMENT REVISION SURGERY ON (B)(6) 2023 AS A RESULT OF THIS EVENT AND THE OUTCOME IS CONSIDERED TO BE RESOLVED. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Failure of Implant

  MAUDE report 19084963 ↗
• InjuryApr 10, 2024Naturally Worn; Naturally Worn

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, THE 58-YEAR-OLD PATIENT HAD A LEFT TKA ON (B)(6) 2015. ON (B)(6) 2020, PATIENT PRESENTED WITH OTHER - CONTRALATERAL TKR WEAR / POLYETHYLENE WEAR WITHOUT EVIDENCE OF OSTEOLYSIS. HAD RIGHT TKR IN 2013 - THIS IS NOW PRODUCING PAIN AND PULLING, X-RAY SHOWS EXCESSIVE MEDIAL POLY WEAR. THIS EVENT IS RELATED TO (B)(4). THE PATIENT UNDERWENT ARTHROSCOPY, BIOPSY AND DEBRIDEMENT OF RIGHT KNEE ON (B)(6) 2021 AND THE OUTCOME OF THIS EVENT IS CONSIDERED TO BE RESOLVED. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Failure of Implant

  MAUDE report 19084695 ↗
• InjuryMar 12, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2022, APPROXIMATELY 7 YEARS, 5 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: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Pain; Sleep Dysfunction

  MAUDE report 18886749 ↗
• InjuryFeb 27, 2024Naturally Worn; Naturally Worn

  STUDY: EXACTECH KNEE REPLACEMENT STUDY; SUBJECT: (B)(6). AS REPORTED, THIS 79 YEAR OLD, MALE PATIENT HAD A LEFT TKA ON (B)(6) 2014. THE PATIENT PRESENTED WITH EFFUSION IN 2022 AND POLYETHYLENE WEAR WITHOUT EVIDENCE OF OSTEOLYSIS - EFFUSION ON (B)(6) 2024. INPATIENT HOSPITALIZATION FOR REVISION - RIGHT TOTAL KNEE REPLACEMENT (POLY EXCHANGE PLUS PATELLA RESURFACING). ACTION TAKEN: REVISION. REVISION IS PERFORMED ON (B)(6) 2024. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED ON (B)(6) 2024. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY RELATED TO DEVICES AND PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN ANTICIPATED.

  Patient problems: Failure of Implant

  MAUDE report 18788502 ↗
• InjuryFeb 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2009, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6)2014, APPROXIMATELY 4 YEARS, 7 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; Unspecified Infection

  MAUDE report 18717502 ↗
• InjuryNov 15, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL RIGHT TKA, THE 58 Y/O MALE PATIENT HAD REVISION SURGERY DUE TO PAIN, INFLAMMATION AND KNEE FAILURE. THERE WAS DISCRETE ASYMMETRY AND SYNOVITIS. PATIENT WAS REVISED TO A OPTETRAK CC. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Failure of Implant; Inflammation; Pain; Synovitis

  MAUDE report 18144567 ↗
• InjurySep 19, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY EIGHT YEARS POST INITIAL LEFT TKA, THE 74 Y/O MALE PATIENT COMPLAINED OF PAIN AND HAD A RECALLED POLY. PATIENT HAD A POLY SWAP. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAY AND IMAGE RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL WILL NOT RELEASE RECALL DEVICES.

  Patient problems: Pain

  MAUDE report 17774523 ↗
• InjuryAug 30, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2015. APPROXIMATELY 7 YEARS AND 9 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT 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: ASEPTIC FAILURE STATUS POST RIGHT KNEE. A THOROUGH SYNOVECTOMY WAS PERFORMED. "THE POLYETHYLENE INSERT WHICH EXHIBITED SIGNIFICANT WE[AR] AROUND THE POST MEDIALLY WAS REMOVED WITH AN OSTEOTOME." A STERILE DRESSING WAS APPLIED. PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO KNOWN COMPLICATIONS.

  Patient problems: Failure of Implant; Joint effusion; Pain; Synovitis

  MAUDE report 17651859 ↗
• InjuryJul 12, 2023Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THAT A 56 Y/O MALE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 7 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A 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. POSTOP DIAGNOSIS: FAILED LEFT TOTAL KNEE ARTHROPLASTY WITH POLYETHYLENE INSERT WEAR, ASEPTIC FEMORAL COMPONENT LOOSENING WITH SEVERE UNDERLYING OSTEOLYSIS, GLOBAL INSTABILITY. PATIENT HAD INCREASING PAIN, SWELLING AND INSTABILITY. FINDINGS: A MARKED EFFUSION WAS NOTED. A LARGE EFFUSION WAS PRESENT WITHIN THE KNEE WITH NORMAL-APPEARING JOINT FLUID. THE KNEE SYNOVIUM WAS MARKEDLY THICKENED AND CONTAINED COPIOUS AMOUNT OF BEAD-LIKE PROJECTIONS WITH A WHITISH-GRAY HUE CONSISTENT WITH PRONOUNCED PARTICLE DISEASE. THE INDWELLING POLYETHYLENE INSERT EXHIBITED MILD MACROSCOPIC POLY WEAR. THE FEMORAL COMPONENT WAS FOUND TO BE GROSSLY LOOSE AND READILY EXPLANTED. THE FEMORAL COMPONENT WAS COMPLETELY DEBONDED FROM THE UNDERLYING CEMENT. UPON REMOVING THE CEMENT

  Patient problems: Cyst(s); Joint Laxity; Joint effusion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 17305123 ↗

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