Optetrak Logic 02-012-44-3013Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10885862173577), received between Aug 11, 2020 and Jul 21, 2025 — classified as 27 injuries.

The most frequently reported specific device problem is “Naturally Worn” (20 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, APPROXIMATELY 9 YEARS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE SURGEON PERFORMED A SYNOVECTOMY SURROUNDING THE AFFECTED KNEE. MILD OSTEOLYSIS WAS PRESENT. THE FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED. THE COMPONENTS WERE REMOVED AND REPLACED BY A COMPETITOR KNEE. 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: Osteolysis; Synovitis

  MAUDE report 22559249 ↗
• InjuryJan 21, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 38 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, IMPLANT PAIN, AMBULATION DIFFICULTIES, FAILURE OF IMPLANT, AND 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: Ambulation or Postural Difficulties; Failure of Implant; Implant Pain; Osteolysis

  MAUDE report 21197232 ↗
• InjuryOct 10, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 7 YEARS AND 1 MONTH POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT COMPLAINED OF PAIN AND WAS REVISED TO COMPETITOR DEVICES. THE PATIENT HAS A RECALLED INSERT AND PATELLA. THIS IS THE FOURTH SURGERY FOR THIS PATIENT. 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: Pain

  MAUDE report 20419269 ↗
• InjuryOct 3, 2024Crack; Naturally Worn; Crack; Naturally Worn

  LEGAL CASE ¿ USA . IT WAS REPORTED THAT APPROXIMATELY 57 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, ABUNDANT WHITE SYNOVIUM AND INFLAMMATORY TISSUE, OSTEOLYSIS, FLUID COLLECTIONS. 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. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0021-2022.

  Patient problems: Failure of Implant; Inflammation; Joint effusion; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 20362558 ↗
• InjurySep 25, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 85 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, INSTABILITY, MODERATE EFFUSION, SIGNIFICANT JOINT LAXITY, VALGUS ALIGNMENT, MILD DELAMINATION OF THE TIBIAL INSERT. 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; Joint effusion; Synovitis

  MAUDE report 20300088 ↗
• InjuryJun 27, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK LOGIC DEVICE ON THE LEFT KNEE, WITH NO REVISION SURGERY REPORTED. IT IS STATED THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: PAIN, STIFFNESS, SWELLING, DISCOMFORT, AND INSTABILITY 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 OTHER INFORMATION AVAILABLE.

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

  MAUDE report 19629690 ↗
• InjuryMay 24, 2024Crack; Unstable; Naturally Worn; Crack; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 82 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SYNOVITIS, PAIN, AND LIMITED MOBILITY. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR, A DISTINCT FISSURE, AND CRACK OF THE POLYETHYLENE COMPONENT. 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; Failure of Implant; Implant Pain; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 19394192 ↗
• InjuryApr 1, 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) 2020 APPROXIMATELY 2 YEARS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Scar Tissue

  MAUDE report 19009661 ↗
• InjuryJan 11, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2018. APPROXIMATELY 4 YEARS AND 6 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 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 ON 19 SEPT 2022 DIAGNOSIS: FAILED BILATERAL TOTAL KNEE REPLACEMENT SECONDARY TO BEARING SURFACE WEAR. FINDINGS: EXUBERANT SYNOVITIS, SYNOVIAL EXPANSION AND FOREIGN BODY TYPE SYNOVIAL REACTION. THE LEFT POLYETHYLENE WAS LESS WORN BUT IT DID HAVE AREAS OF DEFECT, MUCH SMALLER AREAS AND THE LEFT KNEE HAD CORRESPONDINGLY A SMALLER SYNOVIAL REACTION. PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044 (NGG) (MMH), AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFF

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Pain; Synovitis

  MAUDE report 18491037 ↗
• InjuryNov 15, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2018. APPROXIMATELY 3 YEARS AND 8 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: FAILED TOTAL RIGHT KNEE REPLACEMENT. FINDINGS: OSTEOLYSIS DISTAL FEMUR AND PROXIMAL TIBIA. THERE WAS SIGNIFICANT EFFUSION AND SYNOVITIS. NO PURULENCE. THERE WAS DELAMINATION OF THE POLYETHYLENE BUT NO EVIDENCE OF PROSTHESIS LOOSENING. THE POLYETHYLENE WAS REMOVED. PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Insufficient Information; Joint Laxity; Joint effusion; Osteolysis; Synovitis

  MAUDE report 18141326 ↗
• InjuryOct 17, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 8 YEARS AND 2 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: LEFT KNEE REPLACEMENT MECHANICAL COMPLICATION, LEFT KNEE SYNOVITIS, LEFT PATELLAR MALTRACKING. THERE WAS AP FLEXION INSTABILITY. THE LATERAL JOINT WAS MORE LAX THAN THE MEDIAL. REMOVED THE POLYETHYLENE. PERFORMED AND ANTERIOR AND POSTERIOR SYNOVECTOMY. THE SURGEON EXCHANGED THE FIRST POLY WITH A MORE CONSTRAINED POST OPTION. VMO ADVANCEMENT WITH MEDIAL CAPSULE IMBRICATION TO IMPROVE PATELLA TRACKING.

  Patient problems: Joint Laxity; Synovitis

  MAUDE report 17950436 ↗
• InjuryOct 3, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2016. APPROXIMATELY 7 YEARS AND 5 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: FAILED RIGHT TOTAL KNEE. FINDINGS: THE PATELLA BUTTON WAS FOUND TO BE SOLIDLY FIXED TO THE BONE, APPROPRIATELY FIXED AND THE POLYETHYLENE WAS IN GOOD CONDITION AND THIS WAS RETAINED. THE TIBIAL LINER HAD MINIMAL WEAR. NO GROSS DELAMINATION AND THIS WAS REMOVED. THE FEMORAL IMPLANT WAS FOUND TO BE LOOSE, DEBONDED FROM THE UNDERLYING BONE CEMENT MANTLE. THE TIBIAL IMPLANT WAS FOUND TO BE SOLIDLY FIXED, BUT WAS REMOVED TO CHANGE TO A COMPETITOR'S DEVICE. THE PATIENT WAS TRANSFERRED TO THE STRETCHER AND WHEELED TO RECOVERY IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 17861682 ↗
• InjurySep 18, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2018. APPROXIMATELY 3 YEARS AND 7 MONTHS AFTER THE FIRST REVISION THE PATIENT HAD A SECOND RIGHT KNEE REVISION ON (B)(6) 2022. THE PATIENT EXPERIENCED PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS. 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. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Insufficient Information; Joint Laxity; Metal Related Pathology; Osteolysis; Pain; Synovitis

  MAUDE report 17766286 ↗
• InjurySep 13, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2017. THEY SUBSEQUENTLY UNDERWENT LEFT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 5 YEARS 7 MONTHS POST PRIMARY PROCEDURE. REVISION OP REPORT NOTED THAT THE FEMUR WAS GROSSLY LOOSE AND WAS REMOVED BY HAND. THE POLYETHYLENE COMPONENT WAS NOTED TO HAVE SIGNIFICANT WEAR OF BOTH THE MEDIAL AND LATERAL ARTICULAR SURFACE. THE PATELLAR COMPONENT WAS NOTED TO BE INTACT WITHOUT SIGNS OF EXCESSIVE WEAR OR LOOSENING AND WAS THUS LEFT IN PLACE. 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; Pain; Synovitis

  MAUDE report 17736993 ↗
• InjuryJul 11, 2023Unstable; Naturally Worn; Patient Device Interaction Problem; Unstable; Naturally Worn; Patient Device Interaction Problem

  AS REPORTED VIA LEGAL DOCUMENTATION A MALE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 7 YEARS AND 4 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022 DUE TO PAIN AND INSTABILITY OF THE KNEE. 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: PREOPERATIVELY, THAT PATIENT'S PHYSICAL EXAM SUGGESTED MODERATE-SIZED EFFUSION, BUT SIGNIFICANT ANTERIOR DRAW SIGN GREATER THAN 10 MM WITHOUT ENDPOINT WITH THE KNEE FLEXED 90 DEGREES. POSTOP DIAGNOSIS: FAILED LEFT TOTAL KNEE REPLACEMENT SECONDARY TO FLEXION GAP INSTABILITY. THERE WAS A MODERATE SYNOVIAL REACTION IN THE SUPRAPATELLAR POUCH AND SYNOVECTOMY OF THE SUPRAPATELLAR POUCH AND MEDIAL AND LATERAL GUTTERS WAS AFFECTED. POLYETHYLENE INSERT WAS REMOVED AND INSPECTED AND DID NOT SUGGEST THAT IT WAS POLYETHYLENE WEAR BUT SAGITTAL INSTABILITY. POSTERIOR COMPARTMENT OF THE KNEE WAS ALSO DEBRIDED OF EXTRANEOUS FOREIGN BODY REACTIVE SYNOVIUM. THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN STABLE COND

  Patient problems: Discomfort; Joint Laxity; Joint effusion; Pain; Swelling/ Edema

  MAUDE report 17296851 ↗
• InjuryMay 2, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD RIGHT KNEE DONE ON (B)(6) 2015. HE HAD THE RIGHT KNEE REVISED ON (B)(6) 2019, APPROXIMATELY 4 YEARS 3 MONTHS AFTER THEIR INITIAL REPLACEMENT. POSTOPERATIVE DIAGNOSIS: RIGHT KNEE ECCENTRIC POLY WEAR AND FEMORAL COMPONENT LOOSENING. THERE WAS NOTED TO BE MARKED SYNOVIAL HYPERTROPHY WITH POLYETHYLENE DEBRIS IN THE SYNOVIUM. THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE. THERE WAS FOUND TO BE MARKED ECCENTRIC MEDIAL WEAR OF THE TIBIAL POLY COMPONENT ON THE TIBIA. THE TIBIA WAS CHECKED AND STABLE. 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; Swelling/ Edema; Synovitis

  MAUDE report 16853253 ↗
• InjuryMar 6, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT'S SECOND OPTETRAK LOGIC PSC TIBIAL INSERT IMPLANTED IN PLAINTIFF ON (B)(6) 2018 FAILED, CAUSING PLAINTIFF KNEE PAIN AND DIFFICULTY WALKING. DUE TO THE PAIN, DISCOMFORT, AND DIFFICULTY WALKING RELATED TO THE SECOND OPTETRAK LOGIC PSC TIBIAL INSERT IMPLANTED INTO PLAINTIFF, PLAINTIFF WAS FORCED TO UNDERGO A SECOND REVISION SURGERY ON (B)(6) 2019, APPROXIMATELY 1 YEAR 5 MONTHS POST REVISION PROCEDURE, AT WHICH TIME SHE WAS IMPLANTED WITH A THIRD TIBIAL INSERT. AGAIN, TELLINGLY, DURING THE SECOND REVISION PROCEDURE, PLAINTIFF¿S SURGEON NOTED THERE WAS ¿LOOSENING OF THE TIBIAL COMPONENT¿ THAT REQUIRED THE SECOND REVISION SURGERY. THE INSERT IMPLANTED INTO PLAINTIFF¿S KNEE ON (B)(6) 2019 IS AN EXACTECH TRULIANT PSC TIBIAL INSERT¿AN INSERT THAT HAS SINCE BEEN RECALLED. AT THIS TIME, IT IS UNKNOWN WHETHER THE TRULIANT PSC TIBIAL INSERT IMPLANTED INTO PLAINTIFF HAS FAILED LIKE THE PREVIOUS TWO OPTETRAK LOGIC PSC TIBIAL INSERTS IMPLANTED INTO PLAINTIFF, BUT PLAINTIFF CONTINUES TO SUFFER PAIN, DISCOMFORT, AND DIFFICULTY WALKING, ALL RELATING TO THE MULTIPLE REVISION SURGERIES SHE HAS UNDERGONE DUE TO THE FAILURES OF THE TWO OPTETRAK LOGIC P

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Implant Pain

  MAUDE report 16485668 ↗
• InjuryMar 1, 2023Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED BY LEGAL, APPROXIMATELY 7 YEARS POST OP THE INITIAL TKA, THIS FEMALE PATIENT HAS BEEN ADVISED TO UNDERGO AND WILL UNDERGO REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, INSTABILITY AND/OR COMPONENT LOOSENING.

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

  MAUDE report 16461542 ↗
• InjuryMar 1, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED BY THE LEGAL DEPARTMENT THAT THIS MALE PATIENT HAD A RIGHT KNEE REVISION. IT WAS DISCOVERED THAT THE PLASTIC TIBIAL INSERT OF THE DEFECTIVE OPTETRAK LOGIC TOTAL KNEE SYSTEM IMPLANT HAD FAILED, RESULTING IN SYNOVITIS DUE TO POLYWEAR, PERSISTENT RIGHT KNEE EFFUSION AND BONE REABSORPTION.

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

  MAUDE report 16459163 ↗
• InjuryNov 30, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PATIENT'S KNEE WAS REVISED. REASON WAS NOT REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15885337 ↗
• InjurySep 29, 2022Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2016, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 6 YEARS 5 MONTHS POST THE INITIAL IMPLANT PROCEDURE FOR REASONS UNKNOWN. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: Cyst(s); Extraskeletal ossification; Failure of Implant; Joint Laxity; No Clinical Signs, Symptoms or Conditions; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 15504784 ↗
• InjurySep 9, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL TOLLING AGREEMENT, THAT A FEMALE PATIENT, WHO HAD A RIGHT KNEE IMPLANTED ON (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 3 YEARS POST THE INITIAL IMPLANT PROCEDURE FOR UNKNOWN REASONS. NO FURTHER INFORMATION KNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; No Clinical Signs, Symptoms or Conditions; Osteolysis; Pain; Synovitis

  MAUDE report 15396136 ↗
• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY LEGAL, THAT THIS PATIENT'S RIGHT KNEE WAS IMPLANT (B)(6) 2017. REVISION DATE: (B)(6) 2022, REASON FOR THE REVISION WAS NOT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Insufficient Information; Pain

  MAUDE report 15331781 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 2.53 YEARS POST INITIAL LEFT SIDE TKA, THIS FEMALE PATIENT UNDERWENT REVISION DUE TO INSTABILITY. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 13441883 ↗
• InjuryJan 29, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY TWO YEARS POST LEFT TKA, THIS FEMALE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 13390060 ↗