Optetrak Logic 02-012-35-5011Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10885862001931), received between Oct 30, 2020 and Apr 19, 2026 — classified as 50 injuries.

The most frequently reported specific device problem is “Naturally Worn” (43 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 50 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 2026Unstable; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A MALE PATIENT HAD A RIGHT KNEE IMPLANTED WITH AN OPTETRAK LOGIC POLYETHYLENE TIBIAL INSERT, THEN UNDERWENT A REVISION PROCEDURE AND WAS IMPLANTED WITH A SECOND OPTETRAK LOGIC POLYETHYLENE TIBIAL INSERT, STATED THAT HE WILL LIKELY REQUIRE A SECOND REVISION SURGERY ON THE RIGHT KNEE TO REMOVE THE RECALLED OPTETRAK POLYETHYLENE TIBIAL INSERT IN THE FORESEEABLE FUTURE; THERE IS NO CAUSE FOR THIS SUPPOSITION CITED IN THE DOCUMENT. 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. THIS IS 1 OF 2 REPORTS FOR THIS EVENT. THIS IS 1 OF 2 EVENTS FOR THIS PATIENT.

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

  MAUDE report 24921323 ↗
• InjuryMar 6, 2026Unstable; Naturally Worn

  REPORT #2 OF 2 FOR THIS EVENT. IT WAS REPORTED VIA LEGAL DOCUMENTATION A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, TWO (2) YEARS LATE, THE PATIENT EXPERIENCED PAIN, SWELLING, INSTABILITY, BONE LOSS, ASEPTIC (NON-INFECTED) LOOSENING AND AMBULATION DIFFICULTIES. AS A RESULT, THE PATIENT UNDERWENT A REVISION PROCEDURE OF THE FEMORAL AND TIBIAL INSERT COMPONENTS. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 24530792 ↗
• InjuryAug 26, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PROSTHESIS WEAR OF THE POLYETHYLENE LINER. AS A RESULT, APPROXIMATELY TWELVE YEARS AND TEN MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION TO REPLACE THE POLYETHYLENE LINER. THE METAL IMPLANTS WERE WELL FIXED AND REMAIN IMPLANTED. THE PATELLAR IMPLANT HAS SOME WEAR, BUT THE SURGEON CHOSE NOT TO REPLACE IT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 2 FOR THIS EVENT/PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 22896355 ↗
• InjuryApr 4, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 9 YEARS POST OP INITIAL LEFT TKA, THIS 69 Y/O MALE PATIENT WAS REVISED DUE TO A LOOSE FEMUR AND RECALLED POLY. PATIENT COMPLAINED OF PAIN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING - CHAIN OF COMMAND. DUE TO RECALL HOSPITAL WILL NOT RELEASE.

  Patient problems: Discomfort; Pain; Swelling/ Edema

  MAUDE report 21773012 ↗
• InjuryMar 14, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 107 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN. 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: Pain

  MAUDE report 21607405 ↗
• InjuryFeb 10, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 114 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, AMBULATION DIFFICULTIES, JOINT EFFUSION, JOINT LAXITY, DISCOMFORT, OSTEOLYSIS, SWELLING/EDEMA 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; Discomfort; Joint Laxity; Joint effusion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 21345392 ↗
• InjuryDec 30, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 1 YEAR POST THE FIRST REVISION SURGERY, THE PATIENT UNDERWENT A SECOND LEFT SIDE REVISION OF THEIR KNEE DUE TO POLY FAILURE. 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: Insufficient Information

  MAUDE report 21034457 ↗
• InjuryNov 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 9 YEARS POST OP. PATIENT COMPLAINED OF PAIN. LOOSE FEMORAL COMPONENT, RECALLED INSERT AND PATELLA. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain

  MAUDE report 20615263 ↗
• InjurySep 11, 2024Naturally Worn; Naturally Worn

  LEGAL CASE: PATIENT ID: (B)(6). PATIENT COMPLAINED OF PAIN. LOOSE FEMUR. EXPERIENCE REPORT - USA IT WAS REPORTED THAT A 71 YO MALE PATIENT, INITIAL RIGHT KNEE. IMPLANT DATE, (B)(6) 2014, WAS REVISED ON (B)(6) 2023, APPROXIMATELY 8 YEARS 10 MONTHS POST THE INITIAL PROCEDURE, THE PATIENT COMPLAINED OF PAIN. LOOSE FEMUR INDICATED ON THE REPORT PROVIDED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS ANTICIPATED. REASON REPORTED, ¿CHAIN OF COMMAND. DUE TO RECALL HOSPITAL WILL NOT RELEASE IMPLANTS.¿ NO FURTHER INFORMATION. PATIENT REVISED TO EXACTECH DEVICES? YES. NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PRODUCT NOT RETURNING - CHAIN OF COMMAND. DUE TO RECALL HOSPITAL WILL NOT RELEASE IMPLANTS. THE REVISION REPORTED IN CASE-2023-00007604 MAY HAVE BEEN THE RESULT OF POLYETHYLENE WEAR, FEMORAL LOOSENING, AND PAIN. THE PROSTHESIS WEAR MAY HAVE BEEN THE RESULT OF MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, THIRD BODY WEAR, INSTABILITY, PATIENT-RELATED CONDITIONS, OR ANY COMBINATION OF THESE POSSIBILITIES. THE ASEPTIC (NON-INFECTED) FEMORAL LOOSENING MAY HAVE BEEN THE RESU

  Patient problems: Joint effusion; Osteolysis; Synovitis

  MAUDE report 20189385 ↗
• InjuryJul 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 52 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SUFFERING, MENTAL AND EMOTIONAL DISTRESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 19746189 ↗
• InjuryJun 24, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, APPROXIMATELY 7.5 YEARS RIGHT TKA, THE 62 Y/O MALE PATIENT COMPLAINED OF PAIN. PATIENT HAD A LOOSE FEMUR AND RECALLED POLY. 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 DEVICES ARE NOR AVAILABLE FOR EVALUATION DUE TO HOSPITAL WILL NOT RELEASE. RECALL IMPLANTS . IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT UNDERWENT A BILATERAL TOTAL KNEE REPLACEMENT SURGERY AND WAS IMPLANTED WITH AN OPTETRAK DEVICE. THE PATIENT BEGAN EXPERIENCING PAIN, SWELLING, CLICKING, POPPING, AND UNSTEADINESS IN BOTH KNEES. HIS KNEES WOULD ALSO FEEL HOT TO THE TOUCH. THE PATIENT VISITED HIS PHYSICIAN FOR AN ANNUAL FOLLOW-UP APPOINTMENT REGARDING HIS KNEE REPLACEMENTS. HE REPORTED PAIN, SWELLING, CLICKING, POPPING, SENSATIONS OF LOOSENESS, DIFFICULTY ASCENDING AND DESCENDING STAIRS, AND ISSUES MOVING FROM A SEATED TO STANDING POSITION. THE PHYSICIAN ALSO NOTED BILATERAL KNEE EFFUSION AND RECOMMENDED ASPIRATION OF THE KNEE FOLLOWED BY REVISION SURGERY IF THE ASPIRATION REVEALED NO INFECTION IN THE KNEE. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE.

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

  MAUDE report 19596777 ↗
• InjuryJun 20, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 147 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: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 19579340 ↗
• InjuryJun 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 108 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. THE FINDINGS OF THE PROCEDURE STATE THERE WAS EXTENSIVE THICKENED PSEUDOMEMBRANE AND THE TYPICAL SYNOVIAL REACTION SEE WITH REACTION TO POLYETHYLENE PARTICULATE DEBRIS. THE COMPONENTS WERE NOT GROSSLY LOOSE, BUT WERE REMOVED. THERE WAS EXTENSIVE OSTEOLYSIS OF THE POSTEROLATERAL FEMUR, AS WELL AS A SMALLER AREA IN THE CENTRAL TIBIAL PLATEAU. THERE WERE NO SIGNS OF INFECTION. THE POLYETHYLENE COMPONENT SHOWED OBVIOUS WEAR POSTEROMEDIALLY WITH FISSURES AND SOME DEFICIENCY OF POLYETHYLENE FROM EXTENSIVE WEAR. 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; Osteolysis; Synovitis

  MAUDE report 19463648 ↗
• InjuryJun 3, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 111 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, INCREASING PAIN, SWELLING, AND INSTABILITY. UPON THE REVISION OF THE OPTETRAK LOGIC DEVICE, THE PLAINTIFF'S SURGEON OBSERVED SIGNS OF WEAR AND OXIDATION IN THE TIBIAL INSERT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19455277 ↗
• InjuryMay 22, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044) (B)(4) IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 79 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, SWELLING, DISCOMFORT, AND WEAKNESS WHICH NEGATIVELY AFFECTED MOBILITY AND QUALITY OF LIFE, PAIN DURING THE RECUPERATION PERIOD AND REQUIRED PHYSICAL THERAPY, AND ABILITY TO PERFORM NORMAL PHYSICAL ACTIVITIES HAS BEEN LIMITED. 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; Implant Pain; Swelling/ Edema

  MAUDE report 19376778 ↗
• InjuryMay 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 80 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, SWELLING, DISCOMFORT, AND WEAKNESS WHICH NEGATIVELY AFFECTED MOBILITY AND QUALITY OF LIFE, PAIN DURING THE RECUPERATION PERIOD AND REQUIRED PHYSICAL THERAPY. THE ABILITY TO PERFORM NORMAL PHYSICAL ACTIVITIES HAS BEEN LIMITED. 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; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 19374536 ↗
• InjuryMay 21, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 91 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, POSSIBLE NICKEL ALLERGY, EXTENSIVE DAMAGE TO THE POSTERIOR ASPECT OF THE POLYETHYLENE AS WELL AS TO THE POST, SOFT TISSUE CHANGES CONSISTENT WITH EXTENSIVE POLY WEAR, FRAGMENTS OF POLY FOUND IN SOFT TISSUE, POLY WEAR OF THE PATELLA BUTTON, AND A LOOSE FEMORAL COMPONENT. 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.

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

  MAUDE report 19359098 ↗
• InjuryMay 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 144 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE FUTURE REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR. THE PATIENT HAS REPORTED SWELLING, CLICKING AND POPPING IN HIS KNEE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Swelling/ Edema

  MAUDE report 19267016 ↗
• InjuryApr 18, 2024Naturally Worn; Naturally Worn

  IT IS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016, WITH NO REVISION SURGERY REPORTED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19132160 ↗
• InjuryApr 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2020 APPROXIMATELY 4 YEARS AND 9 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 19085898 ↗
• InjuryFeb 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2022, APPROXIMATELY 4 YEARS, 5 MONTHS AFTER INITIAL IMPLANT. ADDITIONALLY, THE PATIENT HAS EXPERIENCED SIGNIFICANT INFLAMMATORY RESPONSE HAVING HAD BLOOD DRAINED FROM HIS KNEE. ON MORE THAN ONE OCCASION, A BAKERS CYST FORMED BEHIND THE KNEE CAUSING ADDITIONAL PAIN TO THE KNEE, CALF, AND FOOT. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION PROVIDED.

  Patient problems: Cyst(s); Discomfort; Failure of Implant; Inflammation; Pain

  MAUDE report 18672965 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH (B)(6) CONDUCTED AN IN PERSON SITE VISIT WITH (B)(6) HOSPITAL. AS A RESULT OF THAT SITE VISIT AND AT EXACTECH'S REQUEST, THE HOSPITAL PROVIDED A RETROSPECTIVE EXCEL LISTING OF REVISION RELATED TO POLYETHYLENE WEAR THAT HAVE BEEN PERFORMED SINCE 2010. THESE CASES HAVE NOT PREVIOUSLY BEEN REPORTED TO EXACTECH AS COMPLAINTS. ON 28-NOV-2023 UPDATES TO THE EXCEL LISTING WERE PROVIDED. THIS 72 Y/O MALE PATIENT WAS IMPLANTED WITH A INSERTO TIBIAL LOGIC PS 5, 11 MM (CAT# 02-012-35-5011 / SERIAL# (B)(6)) ON (B)(6) 2015. THE INSERT WAS MANUFACTURED ON 18-JUN-2012 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS 3.30 YEARS OF SHELF AGE AT THE TIME OF IMPLANT. PATIENT WAS REVISED ON (B)(6) 2015 APPROXIMATELY 0.22 YEARS POST IMPLANT. THE IMPLANT WAS REPLACED DUE TO SUSPECTED INFECTION (NOT CONFIRMED). NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Bacterial Infection; Medical device site infection

  MAUDE report 18332852 ↗
• InjuryOct 31, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY THREE MONTHS POST INITIAL LEFT TKA, THE 72 Y/O MALE PATIENT HAD A REVISION SURGERY WHERE ONLY POLY WAS EXCHANGED. IMAGES RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Osteolysis; Pain; Unspecified Infection

  MAUDE report 18040091 ↗
• InjurySep 6, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT TOTAL KNEE ARTHROPLASTY(B)(6) 2011 DUE TO DEGENERATIVE ARTHRITIS. THE PATIENT SUBSEQUENTLY REQUIRED ARTHROSCOPIC LYSIS OF ADHESIONS AND MANIPULATION OF LEFT KNEE UNDER ANESTHESIA, AND LATER DEVELOPED A PULMONARY EMBOLUS. A CT SCAN CONFIRMED CATASTROPHIC LOOSENING OF THE FEMORAL COMPONENT. THEY UNDERWENT LEFT KNEE REVISION SURGERY (B)(6) 2019, APPROXIMATELY 7 YEARS 7 MONTHS POST PRIMARY PROCEDURE. REVISION SURGEON NOTED THERE WAS EXTENSIVE SYNOVITIS SURROUNDING THE PROSTHETIC KNEE JOINT, AND THAT THE FEMORAL COMPONENT WAS GROSSLY LOOSE. THE TIBIAL COMPONENT HAD EROSIONS ANTERIORLY THAT REMAINED WELL FIXED POSTERIORLY. THERE WAS EXTENSIVE FIBRINOUS DEBRIS AT THE DISTAL FEMUR AND PROXIMAL TIBIA. IT WAS ALSO NOTED THAT NONE OF THE CEMENT ON THE FEMORAL COMPONENT HAD BONDED TO THE FEMORAL COMPONENT. ADDITIONALLY, THE PATIENT HAD A FIRM SOFT TISSUE MASS IN THE POPLITEAL FOSSA, AND A LARGE SYNOVIAL CYST WITH FIBRINOUS DEBRIS AND SYNOVIUM. 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; Failure of Implant; Pain; Synovitis

  MAUDE report 17689860 ↗
• InjuryAug 23, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN; HE HAD A LOOSE FEMUR AND RECALLED POLY. LEFT SIDE REVISION OF EXACTECH IMPLANTS. REPORTED REVISION IS NOT RELATED TO BREAKAGE OF DEVICE AND DID NOT LEAD TO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Implant Pain; Insufficient Information; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 17602526 ↗

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