Optetrak Logic 02-012-44-2011Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10885862173485), received between Aug 6, 2020 and Feb 12, 2025 — classified as 45 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 45 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2025Naturally 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 AND 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: Osteolysis

  MAUDE report 21366760 ↗
• InjuryJan 28, 2025Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA: PATIENT ID: (B)(6) RK REV. AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 5 YEARS AND 4 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 (B)(6) 2022: DIAGNOSIS: RIGHT KNEE ASEPTIC LOOSENING. THERE WAS ABUNDANT SYNOVITIS AND INFLAMED AND IRRITATED TISSUES. POLY WAS REMOVED. FEMORAL COMPONENT WAS REMOVED. THIS DID LOOSEN RELATIVELY EASILY AS EXPECTED AND WAS REMOVED WITH MINIMAL BONE LOSS. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND TAKEN TO RECOVERY ROOM IN STABLE CONDITION. EBI INITIAL SURGERY ATTACHED. HISTORICAL RECORD AND SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. AS DIRECTED BY QA MANAGEMENT: THIS LEGAL COMPLAINT FOR POLYETHYLENE ISSUES OCCURRED IN THE US. THE EVENT DID NOT OCCUR IN, NOR IS IT REPORTABLE FOR AUSTRALIA, BRAZIL, CANADA, EEA/EU, JAPAN, TAIWAN, OR GREAT BRITAIN, EXCLUDING NORTHERN IRELAND. THEREFORE, ONLY THE US REPORTABI

  Patient problems: Failure of Implant; Implant Pain; Synovitis

  MAUDE report 21252873 ↗
• InjuryJan 3, 2025Naturally Worn; Naturally Worn

  REPORTED FROM LEGAL AND OTHER SOURCE. APPROXIMATELY 3.14 YEARS SINCE INITIAL IMPLANT, THIS FEMALE PATIENT UNDERWENT REVISION OF THEIR LEFT SIDE TKA DUE TO ASEPTIC LOOSENING. PREOP DIAGNOSIS ¿ LEFT KNEE FEMORAL LOOSENING, OSTEOLYSIS FINDINGS: GROSSLY LOOSE FEMUR COMPONENT, FEMORAL OSTEOLYSIS, WELL FIXED PATELLA AND TIBIA. INTRAOPERATIVE FROZEN SECTION NOT CONSISTENT WITH INFECTION. PATIENT PRESENTED TO CLINIC WITH LEFT KNEE PAIN. WORK UP REVEALED FEMORAL LOOSENING, C ACNES GREW OUT ON ONE CULTURE IN BROTH ONLY. BELIEVED THIS WAS MOST LIKELY A CONTAMINANT. DECISION TO PROCEED WITH REVISION TKA GIVEN THE PATIENT¿S SIGNIFICANT PAIN. THE FEMORAL COMPONENT WAS FOUND TO BE GROSSLY LOOSE AND WAS EASILY REMOVED WITH A TAMP. THERE WAS EXTENSIVE OSTEOLYSIS OF THE POSTERIOR AND DISTAL FEMORAL CONDYLES LATERALLY AND MEDIALLY. THE TIBIAL COMPONENT WAS FOUND TO BE WELL FIXED. THE PATELLA WAS WELL FIXED AND TRACKED WELL AND WAS NOT REVISED. THE PATIENT¿S OTHER COMPONENTS WERE REVISED TO A COMPETITOR¿S DEVICES.

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

  MAUDE report 21074059 ↗
• InjuryNov 7, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 124 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, RIGHT KNEE CONTRACTURE. 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: Ankylosis; Loss of Range of Motion

  MAUDE report 20626724 ↗
• InjuryNov 6, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 121 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, ANKYLOSIS. 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: Ankylosis; Loss of Range of Motion

  MAUDE report 20622918 ↗
• InjuryNov 6, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 54 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, ANKYLOSIS. 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: Ankylosis; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 20622123 ↗
• InjuryNov 6, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 54 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. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ankylosis; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 20621892 ↗
• InjurySep 5, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 116 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO PROSTHESIS WEAR, ASEPTIC LOOSENING AND SYNOVITIS/OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20145653 ↗
• InjuryAug 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 94 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR PAIN, SWELLING, EFFUSION. 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 effusion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19949472 ↗
• InjuryJun 4, 2024Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 77 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR PAIN IN HER RIGHT KNEE, PERSISTENT SWELLING, STIFFNESS, HYPER-EXTENSION, VARUS ALIGNMENT, SEVERE INSTABILITY, ABNORMAL GAIT, DIFFICULTY ARISING FROM SEATED POSITION, WALKING UP AND DOWN STAIRS, LOOSE POLYETHYLENE COMPONENT AND EXTENSIVE OSTEOLYSIS.. 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; Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema

  MAUDE report 19459018 ↗
• InjuryMay 23, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 97 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FEMORAL COMPONENT LOOSENING, AND CYSTIC DEFECT ON THE FEMORAL MEDIAL CONDYLE. 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: Ambulation or Postural Difficulties; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Failure of Implant; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19381361 ↗
• InjuryMay 6, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 95 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAD A PLANNED REVISION SURGERY FOR POLYETHYLENE WEAR AND OTHER UNSPECIFIED ISSUES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19249028 ↗
• InjuryApr 18, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 6 YEARS AND 10 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19132865 ↗
• InjuryFeb 8, 2024Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA IN (B)(6)2022. IN LIGHT OF UNFORESEEN COMPLICATIONS ASSOCIATED WITH THE KNEE PROSTHESIS, THE SURGEON DEEMED IT NECESSARY TO PERFORM REVISION SURGERY ON (B)(6)-2023. IT WAS IDENTIFIED THAT THERE WAS MOBILIZATION OF THE TIBIA, ACCOMPANIED BY ABNORMAL WEAR OF THE POLYETHYLENE COMPONENT. THE PATIENT UNDERWENT A TOTAL KNEE REVISION AND A NON-EXACTECH PROSTHESIS WAS IMPLANTED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18671075 ↗
• InjuryJan 16, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 9 YEARS AND 4 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) 2023DIAGNOSIS: FAILED RIGHT KNEE REPLACEMENT FINDINGS: LOOSE FEMORAL AND TIBIAL IMPLANTS - REMOVED EASILY WITH MODERATE BONE LOSS. VERY LARGE POSTERIOR MEDIAL FLUID COLLECTION - THICK VISCOUS LIGHT BROWN - UNUSUAL APPEARANCE LIKELY RELATED TO SEVERE POLY WEAR. THERE WAS EXTENSIVE SOFT TISSUE DEBRIS THROUGHOUT THE KNEE JOINT CONSISTENT WITH A SYNOVITIS FROM A POLYETHYLENE REACTION TO THE TISSUES. THERE WAS TINY, SMALL BALLS OF LIGHT BROWN SYNOVIUM ALONG WITH A "PESUDO-CAPSULE" OF DENSE SOFT TISSUE RIND. THE SURGEON EXAMINED THE POLYETHYLENE - EXCESSIVE WEAR WAS PRESENT WITH SIGNS OF OXIDATION/YELLOW DISCOLORATION, PITTING, CRACKING AND DELAMINATION OF THE POLY. DISTAL FEMORAL BONE LOSS WAS MODERATE. THE TIBIAL BONE LOSS WAS EXTENSIVE AND REQUIRED PLACEMENT

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

  MAUDE report 18517447 ↗
• InjurySep 12, 2023Naturally Worn; Naturally Worn

  AS REPORTED BY THE LEGAL BRIEF, ON (B)(6) 2016, A PATIENT UNDERWENT BILATERAL TOTAL KNEE REPLACEMENT SURGERY. DURING THIS PROCEDURE, PATIENT WAS IMPLANTED WITH AN OPTETRAK LOGIC POLYETHYLENE PSC TIBIAL INSERT IN THE RIGHT KNEE. IT IS STATED THAT IT IS LIKELY THE PATIENT WILL UNDERGO REVISION SURGERY ON HER RIGHT KNEE TO REMOVE THE "FAILED" OPTETRAK DEVICE, THERE IS NO INFORMATION IF THE PATIENT WAS REVISED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 17732778 ↗
• InjuryAug 24, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY (B)(6)2017. THEY UNDERWENT LEFT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 5 YEARS 3 MONTHS POST PRIMARY PROCEDURE. (B)(6) 2023 OP REPORT POSTOPERATIVE DIAGNOSIS: OSTEOLYSIS AND MECHANICAL LOOSENING OF PROSTHETIC LEFT KNEE. THE SURGEON NOTED THAT THERE WAS SOME MILD GRAY, REACTIVE SYNOVITIS CONSISTENT WITH POLYETHYLENE WEAR. ON INSPECTION OF THE POLYETHYLENE INSERT, THERE WAS SOME WEAR THROUGHOUT. THE PATELLA HAD PARTIALLY FRAGMENTED, AND REMAINING CEMENT AND FIBRINOUS TISSUE 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: Discomfort; Failure of Implant; Implant Pain; Muscle Weakness/Atrophy; Osteolysis; Synovitis

  MAUDE report 17614554 ↗
• InjuryJul 13, 2023Mechanical Problem; Peeled/Delaminated; Unstable; Naturally Worn; Mechanical Problem; Peeled/Delaminated; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2013. APPROXIMATELY 9 YEARS AND 3 MONTHS 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: DIAGNOSIS: LEFT TKR PERIPROSETHETIC OSTEOLYIS. THERE WAS SIGNIFICANT EFFUSION AND SYNOVITIS. THERE WAS DELAMINATION OF THE POLYETHYLENE AND EVIDENCE OF FEMORAL PROSTHESIS LOOSENING. A STERILE COMPRESSIVE DRESSING WAS APPLIED. PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Arthralgia; Implant Pain; Joint Laxity; Joint effusion; Loss of Range of Motion; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 17318801 ↗
• InjuryJul 6, 2023Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THIS PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6)2019 AND THEN APPROXIMATELY 4 YEARS, 2 MONTHS LATER EXPERIENCED A SURGICAL REVISION ON (B)(6)2023. PATIENT REVISED TO EXACTECH DEVICES. REVISION OPERATIVE REPORT OF 11 APR 2023. POST OPERATIVE DIAGNOSIS: FAILED TOTAL KNEE, CATASTROPHIC POLYETHYLENE FAILURE-RECALLED IMPLANT, AND LOOSE FEMORAL COMPONENT. PROCEDURE: A MEDIAL PARAPATELLAR ARTHROTOMY WAS MADE, THERE WAS SIGNIFICANT DEBRIS PRESENT IMMEDIATELY BUT THE SYNOVIAL FLUID WAS CLEAR, STRAW-COLORED. THERE WAS SIGNIFICANT POLY DEBRIS EMBEDDED INTO THE SYNOVIAL TISSUE WITH INFLAMMATORY CHANGES. THE POLYETHYLENE LINER HAD CATASTROPHICALLY FAILED. THE PATELLAR BUTTON HAD SIGNIFICANT WEAR ALONG WITH SEVERAL PITS WITHIN THE BUTTON. DURING IMPACTION OF THE LINER, IT BECAME EVIDENT THAT THE FEMORAL COMPONENT WAS GROSSLY LOOSE, THE TIBIAL AND FEMORAL COMPONENTS WERE REVISED. DEVICE TRIAL WAS COMPLETED, AND NEW DEVICES WERE IMPLANTED. DRESSINGS WERE APPLIED, THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. HOSPITAL CARE: ADMITTED (B)(6)2023/ DISCHARGED (B)(6)2023. THERE IS NO OTHER PATIENT DEMOGRAPHIC

  Patient problems: Joint Laxity; Pain; Synovitis

  MAUDE report 17269475 ↗
• InjuryJul 6, 2023Crack; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Crack; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THIS PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014 AND THEN APPROXIMATELY 8 YEARS, 5 MONTHS LATER EXPERIENCED A SURGICAL REVISION ON (B)(6) 2023. PATIENT REVISED TO COMPETITOR¿S DEVICES. REVISION OPERATIVE REPORT OF (B)(6) 2023. POST OPERATIVE DIAGNOSIS: POLY WEAR, INSTABILITY, ASEPTIC LOOSENING OF FEMORAL COMPONENT. CLINICAL HISTORY-PATIENT PRESENTS WITH PAINFUL TKA AND RECALLED PARTS. THE PATIENT IS FOUND TO HAVE PROGRESSIVE POLYETHYLENE WEAR AS WELL AS INSTABILITY OF THE TOTAL KNEE. PROCEDURE: THE PATELLAR BUTTON WAS FOUND TO BE INTACT WITH SOME SURFACE WEAR. THE POLYETHYLENE WAS NOTED TO BE GROSSLY DAMAGED WITH CRACKS THROUGHOUT. THE FEMORAL COMPONENT WAS COMPLETELY DEBONDED FROM ITS CEMENT MANTLE. WHEN FEMORAL COMPONENT WAS REMOVED AORI TYPE IIA BONE LOSS WAS FOUND, WORSE ON THE LATERAL COMPARED TO MEDIAL SIDE, AND OSTEOLYSIS AFFECTING BOTH POSTERIOR CONDYLES. TIBIAL COMPONENT WAS REMOVED WITH MINIMAL BONE LOSS. BONE LOSS OF THE TIBIAL METAPHYSIS WARRANTED THE USE OF A CONE. THE PATELLAR COMPONENT WAS REMOVED. COMPONENTS WERE TRIALED AND THEN THE DEVICES WERE IMPLANTED. DRESSINGS WERE APPLIED, THE PATIENT WAS TR

  Patient problems: Joint Laxity; Pain

  MAUDE report 17267733 ↗
• InjuryJun 21, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2012. APPROXIMATELY 10 YEARS AND 1 MONTH 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 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. REVISION OP REPORT (B)(6) 2022 POSTOPERATIVE DIAGNOSIS: INSTABILITY OF PROSTHETIC KNEE.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 17173561 ↗
• InjuryJun 12, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  DOB: (B)(6) 1976. AS REPORTED VIA LEGAL DOCUMENTATION THE 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. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, INSTABILITY, AND COMPONENT LOOSENING. 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Insufficient Information; Joint Laxity; Pain; Scar Tissue; Synovitis

  MAUDE report 17109935 ↗
• InjuryApr 11, 2023Unstable; Insufficient Device Problem Information; Unstable; Insufficient Device Problem Information

  ADDITIONAL INFORMATION- APPROXIMATELY 5 YEARS AND 8 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD THE RIGHT KNEE REVISED ON (B)(6) 2022 FOR INSTABILITY OF PROSTHETIC KNEE, RIGHT REVISION TOTAL KNEE ARTHROPLASTY. THERE WERE NO COMPLICATIONS PER THE REVISION OPERATIVE REPORT AND NO UNUSUAL OR NOTABLE ISSUES IN THE REPORT. THE PATIENT HAD A BULKY COMPRESSIVE DRESSING APPLIED AND WAS THEN TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2022 AND THEN DISCHARGED 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.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 16714260 ↗
• InjuryApr 7, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL NOTIFICATION THAT ON OCTOBER 29, 2014, THE PATIENT UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT SURGERY WHERE SHE WAS IMPLANTED WITH AN OPTETRAK LOGIC PSC POLYETHYLENE TIBIAL INSERT (SERIAL #: (B)(4)). THEN, ON (B)(6) 2017 , APPROXIMATELY 2 YEARS 6 MONTHS POST IMPLANT, SHE UNDERWENT A RIGHT KNEE REVISION SURGERY DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE OPTETRAK LOGIC POLYETHYLENE TIBIAL INSERT AND WAS IMPLANTED WITH AN OPTETRAK LOGIC PSC POLYETHYLENE TIBIAL INSERT. IT IS STATED THAT THE PATIENT EXPERIENCES PAIN IN BOTH OF HER KNEES AND WILL LIKELY REQUIRE RE-REVISION SURGERIES IN BOTH KNEES TO REMOVE THE OPTETRAK DEVICES CURRENTLY IMPLANTED. 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

  MAUDE report 16703995 ↗
• InjuryApr 7, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL NOTIFICATION THAT ON (B)(6) 2015, THE PATIENT UNDERWENT LEFT KNEE REPLACEMENT WHERE SHE WAS IMPLANTED WITH AN OPTETRAK LOGIC PSC POLYETHYLENE TIBIAL INSERT. THEN, ON (B)(6) 2018, APPROXIMATELY 2 YEARS 2 MONTHS AFTER IMPLANT, THE PATIENT HAD A LEFT KNEE REVISION DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE OPTETRAK LOGIC POLYETHYLENE TIBIAL INSERT AND WAS IMPLANTED WITH ANOTHER OPTETRAK LOGIC PSC POLYETHYLENE TIBIAL INSERT. IT IS STATED THAT THE PATIENT EXPERIENCES PAIN IN BOTH OF HER KNEES AND WILL LIKELY REQUIRE RE-REVISION SURGERIES IN BOTH KNEES TO REMOVE THE OPTETRAK DEVICES CURRENTLY IMPLANTED. 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Aseptic loosening; Balance Problems; Discomfort; Failure of Implant; Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema

  MAUDE report 16702929 ↗