Optetrak Logic 02-012-44-4013Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10885862173652), received between Oct 14, 2019 and May 7, 2026 — classified as 35 injuries.

The most frequently reported specific device problem is “Naturally Worn” (29 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2026Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED OSTEOLYSIS. AS A RESULT, THE PATIENT UNDERWENT A LEFT KNEE REVISION AN UNKNOWN AMOUNT OF TIME AFTER INITIAL IMPLANTATION. NO FURTHER INFORMATION AVAILABLE. NO FURTHER PATIENT IMPACT REPORTED.

  Patient problems: Osteolysis

  MAUDE report 25112402 ↗
• InjuryFeb 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT HAD A KNEE REVISION PROCEDURE 123 MONTHS AFTER THEIR INITIAL PROCEDURE. THE PATIENT STATED THE KNEE IMPLANT THEY RECEIVED IS DEFECTIVE AND THEY ARE CURRENTLY EXPERIENCING STIFFNESS AND PAIN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Unspecified Musculoskeletal problem

  MAUDE report 21313246 ↗
• InjuryJan 13, 2025Naturally Worn; Naturally Worn

  "LEGAL CASE ¿ USA PATIENT ID: + LEFT KNEE IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 58 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, JOINT PAIN, JOINT SWELLING, STIFFNESS, TISSUE DAMAGE, LOOSENING, OSTEOLYSIS. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Inflammation; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 21143755 ↗
• InjuryNov 6, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 82 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.

  Patient problems: Insufficient Information

  MAUDE report 20622770 ↗
• InjuryOct 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 110 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20431647 ↗
• InjurySep 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 48 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.

  Patient problems: Insufficient Information

  MAUDE report 20180441 ↗
• InjuryJul 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 79 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, TIBIAL PITTING AND DELAMINATION. 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; Implant Pain; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19837913 ↗
• InjuryJul 26, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 106 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 19836798 ↗
• InjuryJun 24, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH A TRULIANT DEVICE ON THE RIGHT KNEE, WITH NO REVISION SURGERY REPORTED. IT IS STATED THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: PAIN AND SUFFERING, PAST COST OF MEDICAL CARE, FUTURE COST OF MEDICAL CARE, LOSS OF EARNING CAPACITY AND MENTAL AND EMOTIONAL DISTRESS. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Emotional Changes; Pain

  MAUDE report 19601059 ↗
• InjuryJun 5, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 87 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING AND INSTABILITY. DURING THE SURGERY, IT WAS OBSERVED THAT THE PATIENT HAS SIGNIFICANT BONE LOSS IN THE TIBIA AND LOOSENING OF THE FEMORAL COMPONENT. THE SURGEON REPLACED AND REVISED THE FEMORAL AND TIBIAL COMPONENTS. 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; Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema

  MAUDE report 19473019 ↗
• InjuryMay 28, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE ARTHROPLASTY ON (B)(6) 2017, WITH NO REVISION SURGERY REPORTED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Discomfort; Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 19406123 ↗
• InjuryMay 20, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 93 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, OSTEOLYSIS AND POLYMERIC-INDUCED SYNOVITIS. 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; Scar Tissue; Synovitis

  MAUDE report 19355212 ↗
• InjuryMay 20, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 61 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANTS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Osteolysis; Synovitis

  MAUDE report 19350090 ↗
• InjuryMay 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT KNEE ARTHROPLASTY ON (B)(6) 2018, WITH NO REVISION SURGERY REPORTED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Implant Pain; Swelling/ Edema; Synovitis

  MAUDE report 19282513 ↗
• InjuryMay 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 128 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, RIGHT KNEE ARTHROPLASTY FAILURE, ARTHROFIBROSIS, INSTABILITY, AND SEVERE OSTEOLYSIS. 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; Failure of Implant; Insufficient Information; Osteolysis

  MAUDE report 19280583 ↗
• InjuryApr 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019, WITH NO REPORTED REVISION. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 19132029 ↗
• InjuryFeb 15, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2021 APPROXIMATELY 5 YEARS AND 1 MONTH AFTER INITIAL IMPLANT. ADDITIONALLY, THE PATIENT HAS EXPERIENCED INCREASING PAIN, SWELLING, AND INSTABILITY IN HER RIGHT KNEE. MOREOVER, WEAR OF THE ARTICULAR BEARING SURFACE, I.E., THE POLYETHYLENE COMPONENT, WAS OBSERVED AS WELL AS REACTIVE GRANULATION TISSUE AND SYNOVITIS. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 18710929 ↗
• InjuryDec 14, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 7 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT 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 6 OCT 2022 DIAGNOSIS: FAILED RIGHT KNEE FINDINGS: SIGNIFICANT POLY WEAR WITH OSTEOLYSIS CHANGES TO THE BONE AND THE SOFT TISSUES. LOOSE FEMORAL IMPLANT - REMOVED EASILY WITH MINIMAL BONE LOSS. THE FEMORAL IMPLANT WAS EASILY REMOVED BECAUSE IT HAD MINIMAL INGROWTH I CEMENT ADHERING IT TO THE BONE. RECIPROCATING SAW USED TO PASS ALONG THE TIBIA AND IMPLANT IT WAS REMOVED EASILY DUE TO MINIMAL BONE INGROWTH.

  Patient problems: Failure of Implant

  MAUDE report 18324142 ↗
• InjuryJul 17, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE MALE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 6 YEARS AND 3 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: PAINFUL LEFT KNEE REPLACEMENT WITH OSTEOLYSIS IT WAS NOTED THAT THE POLYETHYLENE INSERT HAD SOME WEAR ON THE POST AND MEDIAL ASPECT. THE TIBIAL TRAY DESPITE EXTENSIVE OSTEOLYSIS WAS WELL FIXED. THE PATIENT WAS AWAKENED, MOVED TO THE STRETCHER AND TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. THERE WERE NO IMMEDIATE COMPLICATIONS.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 17333415 ↗
• InjuryJul 7, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6)2017 AND THEN APPROXIMATELY 4 YEARS, 4 MONTHS LATER EXPERIENCED A SURGICAL REVISION PROCEDURE ON (B)(6)2021. THE REVISION IS REPORTED TO BE FOR: JOINT PAIN, JOINT SWELLING AND STIFFNESS, TISSUE DAMAGE, REVISION SURGERY, LOOSENING, INSTABILITY, POLYETHYLENE WEAR, OSTEOLYSIS, SYNOVITIS, AND REVISION WITH BONE GRAFT. 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.

  Patient problems: Failure of Implant; Implant Pain; Insufficient Information; Joint Laxity; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 17277698 ↗
• InjuryJul 6, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020 AND THEN APPROXIMATELY 2 YEARS 8 MONTHS LATER EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023. REVISION OPERATIVE REPORT OF (B)(6) 2023. POST-OPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE REPLACEMENT SECONDARY TO WEAR OF THE BEARING SURFACE. PROCEDURE: REVISION LEFT TOTAL KNEE REPLACEMENT, TIBIAL COMPONENT POLYETHYLENE EXCHANGE. THE TIBIAL INSERT WAS THEN REMOVED, AND LAMINA SPREADERS WERE PLACED INTO THE FLEXION GAP. FLEXION GAP WAS DISTRACTED SO THAT THE POSTERIOR COMPARTMENT OF THE KNEE COULD BE EXPOSED AND DEBRIDED OF THE ABNORMAL HYPERTROPHIC SYNOVIUM. THE SYNOVECTOMY WAS ATTEMPTED TO BE AS COMPLETE AS POSSIBLE TO REMOVE ALL ABNORMAL SYNOVIAL TISSUES AND ANY FURTHER BURDEN OF POLYETHYLENE DEBRIS. THE POSTERIOR TIBIAL AREAS WERE DEBRIDED OF ANY ABNORMAL SYNOVIUM AND THEN A TRIAL REDUCTION WAS PERFORMED USING A 17 MM PSC INSERT FOR THE SIZE 4 COMPONENT. FINAL CHECK FOR ANY LOOSENING OF THE FEMORAL COMPONENT OR TIBIAL COMPONENT WAS MADE AND THERE WAS ABSOLUTELY NO SIGN OF ANY LOOSENING OR OSTEOLYSIS AROUND ANY OF THE COMPONENTS. DEVICES WERE TRIALED AND THE IMPLANTATION

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

  MAUDE report 17274855 ↗
• InjuryJun 16, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Lack of Effect; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Lack of Effect

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT ON (B)(6) 2015. THEY SUBSEQUENTLY UNDERWENT LEFT KNEE REVISION ON (B)(6) 2022, APPROXIMATELY 7 YEARS 8 MONTHS AFTER THEIR PRIMARY SURGERY. (B)(6) 2022 OP REPORT NOTED EXTENSIVE SYNOVITIS AND PSEUDOMEMBRANE FORMATION AND A LARGE EFFUSION. THERE WAS EARLY WEAR ALONG THE POST ON THE POLYETHYLENE INSERT. ALL COMPONENTS WERE WELL FIXED. THERE WAS A SMALL AREA OF OSTEOLYSIS MEDIAL PROXIMAL TIBIA WHICH WAS DEBRIDED. 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; Insufficient Information; Joint effusion; Medical device site infection; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 17142712 ↗
• InjuryApr 19, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE CHARLES NELSON RK REV AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD A RIGHT KNEE REVISION (B)(6) 2015. THE PATIENT PRESENTS WITH A PAINFUL AND UNSTABLE RIGHT KNEE REPLACEMENT. THE PATIENT WAS NOTED TO HAVE ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND MARKED OSTEOLYSIS. THE PATIENT HAS FAILED CONSERVATIVE MANAGEMENT INCLUDING ACTIVITY MODIFICATION AND ANTI-INFLAMMATORY MEDICATIONS. THEY HAD RIGHT KNEE REVISION (B)(6) 2023, APPROXIMATELY 7 YEARS, 5 MONTHS AFTER THEIR INITIAL REPLACEMENT. PRE & POST OP DIAGNOSIS FOR REVISION: RIGHT KNEE FAILED TOTAL KNEE REPLACEMENT, RIGHT KNEE ASEPTIC LOOSENING FEMORAL COMPONENT, RIGHT KNEE OSTEOLYSIS SEVERE. FROM DESCRIPTION OF PROCEDURE: THERE WAS VERY EXTENSIVE SYNOVITIS AND A VERY THOROUGH SYNOVECTOMY OF THE JOINT WAS PERFORMED. THE POLYETHYLENE LINER WAS REMOVED. THERE WAS NOTED TO BE WEAR OF THE LINER WITH DELAMINATION. NEXT THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE AND IT WAS REMOVED. THERE WAS SIGNIFICANT FIBROUS TISSUE BENEATH IT WITH MARKED OSTEOLYSIS. THERE WAS NO EVIDENCE OF INFECTION GROSSLY ALTHOUGH MULTIPLE SPECIMENS WERE SENT TO PATHOLOGY. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. NO

  Patient problems: Discomfort; Failure of Implant; Implant Pain; Joint Laxity; Muscle Weakness/Atrophy; Osteolysis; Scar Tissue; Synovitis

  MAUDE report 16771103 ↗
• InjuryApr 10, 2023Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE: (B)(6). REVISION LEFT TOTAL KNEE REPLACEMENT. PER INFORMATION RECEIVED BY THE LEGAL DEPARTMENT, THE PATIENT PRESENTS WITH A PAINFUL AND UNSTABLE LEFT KNEE REPLACEMENT. THE PATIENT WAS NOTED TO HAVE ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND MARKED OSTEOLYSIS. THE PATIENT HAS FAILED CONSERVATIVE MANAGEMENT INCLUDING ACTIVITY MODIFICATION, ANTI-INFLAMMATORY MEDICATIONS, AND INJECTIONS. ALL OPTIONS WERE DISCUSSED IN DETAIL WITH THE PATIENT AND THEY DECIDED TO PROCEED WITH REVISION LEFT TOTAL KNEE REPLACEMENT ON (B)(6) 2022. INITIAL REPLACEMENT WAS PERFORMED ON (B)(6) 2013. THE POLYETHYLENE LINER WAS REMOVED. THERE WAS NOTED TO BE WEAR OF THE LINER WITH DELAMINATION. NEXT THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE AND IT WAS REMOVED. THERE WAS SIGNIFICANT FIBROUS TISSUE BENEATH IT WITH MARKED OSTEOLYSIS. THE MEDIAL FEMORAL CONDYLE WAS ALL ERODED. THERE WAS NO EVIDENCE OF INFECTION GROSSLY ALTHOUGH MULTIPLE SPECIMENS WERE SENT TO PATHOLOGY. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. NO EBI INFO COULD BE FOUND.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Implant Pain; Joint Laxity; Osteolysis; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 16706467 ↗
• InjuryMar 9, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL RIGHT TOTAL KNEE REPLACEMENT AND WAS IMPLANTED WITH AN EXACTECH OPTETRAK COMPREHENSIVE TOTAL KNEE REPLACEMENT ON (B)(6) 2016. ON OR ABOUT (B)(6) 2022, APPROXIMATELY 6 YEARS 4 MONTHS POST INITIAL PROCEDURE, PLAINTIFF UNDERWENT A REVISION SURGERY ON HIS RIGHT KNEE FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, INSTABILITY, AND/OR COMPONENT LOOSENING. THE OPERATIVE REPORT FOR PLAINTIFF¿S REVISION KNEE REPLACEMENT NOTES THAT ¿THERE WAS VERY EXTENSIVE SYNOVITIS,¿ ¿THERE WAS NOTED TO BE WEAR OF THE [POLYETHYLENE] LINER,¿ AND ¿THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE . THERE WAS SIGNIFICANT FIBROUS TISSUE BENEATH IT WITH SOME OSTEOLYSIS,¿ AMONG OTHER ISSUES. ADDITIONALLY, THE REVISION PATHOLOGY REPORT NOTED ¿THE SYNOVIAL AND CAPSULAR TISSUE FRAGMENTS ARE EXPANDED BY A MONONUCLEAR AND GIANT CELL REACTION TO A MIXTURE OF LARGE AND SMALL PARTICLES OF REFRACTILE MATERIAL CONSISTENT WITH POLYETHYLENE DEBRIS.¿ PLAINTIFF¿S MEDICAL RECORDS REFLECT THE TYPICAL FINDINGS OF ACCELERATED AND PREVENTABLE POLYETHYLENE WEAR DUE TO DEFECTIVE DESIGN OF THE DEVICE AND A MANUFACTURING DEFECT OF THE DEVIC

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

  MAUDE report 16518569 ↗