Truliant 02-022-35-4009Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10885862304438), received between Oct 14, 2019 and Mar 2, 2026 — classified as 34 injuries.

The most frequently reported specific device problem is “Naturally Worn” (24 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-0023-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Naturally Worn

  AS REPORTED, APPROXIMATELY 3 YEARS POST OP THE INITIAL LEFT TKA, THE PATIENT WAS REVISED DUE TO A LOOSE FEMUR. PATIENT COMPLAINED OF PAIN. DUE TO RECALL SURGEON USED A COMPETITOR FOR REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING, DUE TO RECALL HOSPITAL WILL NOT RELEASE THE IMPLANTS.

  Patient problems: Pain

  MAUDE report 24490063 ↗
• InjuryAug 5, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED, APPROXIMATELY 24 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE; THE PATIENT EXPERIENCED PAIN. SUBSEQUENTLY, THE PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE. POST OPERATIVE NOTES WERE PROVIDED. POST OPERATIVE DIAGNOSIS NOTED PROSTHESIS WEAR ON TIBIAL INSERT AND ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. THE PATIENT WAS AWOKEN FROM ANESTHESIA AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 22715105 ↗
• InjuryJul 29, 2025Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TKA APPROXIMATELY 5 YEARS AND 6 MONTHS AGO. SUBSEQUENTLY, THE PATIENT REPORTED EXPERIENCING PAIN. AS A RESULT, THE PATIENT IS SCHEDULED FOR A REVISION SURGERY ON A FUTURE DATE. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 22645656 ↗
• InjuryMar 12, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION APPROXIMATELY 35 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT THE PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND PAIN. A REVISION OPERATIVE REPORT WAS PROVIDED. POST OPERATIVE DIAGNOSIS NOTED: FAILED LEFT KNEE ARTHROPLASTY SECONDARY TO FLEXION INSTABILITY. IT WAS NOTED THE PATIENT'S LABORATORY ANALYSIS WAS NEGATIVE FOR EVIDENCE OF INFECTION. INTRAOPERATIVELY, THE SURGEON INSPECTED THE POLYETHYLENE AND NOTED IT TO BE WELL-FIXED WITHOUT SIGNIFICANT SURFACE DAMAGE, DELAMINATION OR PITTING. THE SURGEON PERFORMED EXCISION OF SCAR TISSUE TO FACILITATE TRANSLATION OF THE PATELLA INTO THE LATERAL GUTTER. FINDINGS ALSO INDICATED BONE LOSS OF THE TIBIA AND FEMUR. NO OTHER 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; Emotional Changes; Joint Laxity; Osteolysis; Pain; Scar Tissue

  MAUDE report 21585577 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 2 YEARS 4 MONTHS POST OPERATION. THE PATIENT HAD INFECTION PRESENT. SURGEON SCHEDULED THE PATIENT FOR AN IRRIGATION AND DEBRIDEMENT OF THEIR RIGHT TOTAL KNEE ARTHROPLASTY WITH A TIBIAL POLY INSERT SWAP. THE TOTAL JOINT WAS EXPOSED, IRRIGATED, AND DEBRIDED. A SYNOVECTOMY WAS PERFORMED. THE TIBIAL POLY INSERT WAS REPLACED WITH A NEW ONE. ANTIBIOTIC BEADS WERE PLACED LOCALLY INTO THE WOUND. THE JOINT WAS CLOSED AND THE PATIENT LEFT THE OR STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 21262766 ↗
• InjuryJan 23, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 6 YEARS AND 2 MONTHS POST INITIAL PROCEDURE. PATIENT COMPLAINED OF PAIN AND HAD A RECALLED POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain

  MAUDE report 21218039 ↗
• InjuryDec 6, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 10 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS ASEPTIC LOOSENING OF THE PATELLAR COMPONENT AND FLEXION INSTABILITY FOLLOWING A FALL. 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: Failure of Implant; Implant Pain; Joint Laxity; Synovitis

  MAUDE report 20864977 ↗
• InjuryOct 23, 2024Corroded; Naturally Worn; Corroded; Naturally Worn

  LEGAL CASE ¿ USA IT WAS REPORTED THAT APPROXIMATELY 58 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PERSISTENT KNEE PAIN, INFLAMMATION, OSTEOLYSIS AND 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. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0023-2022.

  Patient problems: Implant Pain; Inflammation; Osteolysis; Pain; Synovitis

  MAUDE report 20516690 ↗
• InjuryAug 27, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044) (NGG) (MMH). (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 37 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, STIFFNESS, SWELLING, DISCOMFORT, AND INSTABILITY. 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; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 20081142 ↗
• InjuryAug 5, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 11 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING SIGNIFICANT PAIN AND DISCOMFORT. GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; METALLOSIS; SOFT TISSUE DAMAGE; INFECTION; AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE. 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; Emotional Changes; Osteolysis; Pain

  MAUDE report 19910050 ↗
• InjuryJul 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 40 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE FOR PROSTHESIS WEAR. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. 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 FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 19827431 ↗
• InjuryMay 21, 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 THAT APPROXIMATELY 36 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS ASEPTIC LOOSENING OF THE FEMORAL COMPONENT, INCREASED SWELLING AND INSTABILITY AFTER A FALL ONTO THE RIGHT KNEE. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED LOOSENING OF THE FEMORAL COMPONENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19358016 ↗
• InjuryMay 7, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 69 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE FUTURE REVISION SURGERY FOR POLYETHYLENE WEAR. THE PATIENT HAS REPORTED SEVERE PAIN, SCARRING, SWELLING, EFFUSION, ANTALGIC GAIT, INFLAMMATION, KNEE POPPING AND CRACKING, INSTABILITY, ANXIETY, EMOTIONAL DISTRESS, FUTURE SURGERIES, GENERAL DAMAGES, AND OTHER INJURIES WHICH HAVE RESULTED IN PAST AND FUTURE MEDICAL EXPENSES. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19259368 ↗
• InjuryApr 24, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT RECEIVED A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019, THERE HAS BEEN NO REVISION REPORTED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19177027 ↗
• InjuryApr 23, 2024Adverse 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 THE EXACTECH TRULIANT KNEE CLINICAL STUDY, APPROXIMATELY ONE YEAR POST INITIAL LEFT TKA, THE 67 Y/O FEMALE PRESENTED WITH REDNESS, PATIENT HAD SWELLING LEFT KNEE. X-RAY SHOWED ANTERIOR SOFT TISSUE SWELLING, NARROW ZONES OF PERIPROSTHETIC LUCENCY. PATIENT WAS ADMITTED AND RX'D DAPTOMYCIN. THE SURGEON PERFORMED LTK REVISION FOR INCISION AND DRAINAGE WITH POLY EXCHANGE. PATIENT WAS DISCHARGED HOME SEVEN DAYS LATER WITH RX'D PAIN MEDICATION AND ASA X4 WEEKS AND ANTIBIOTIC X6 WEEKS. PER CLINICAL REPORT, THE REPORTED EVENT IS NOT RELATED TO THE DEVICE BUT DEFINITELY RELATED TO THE PROCEDURE.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 19165588 ↗
• InjuryFeb 14, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017, WITH NO REVISION SURGERY REPORTED. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Insufficient Information; Muscle Weakness/Atrophy; Pain; Unspecified Musculoskeletal problem

  MAUDE report 18702238 ↗
• InjurySep 13, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD LEFT KNEE REPLACEMENT SURGERY ON (B)(6) 2019. THEY HAVE NOT YET UNDERGONE REVISION, BUT CLAIM TO HAVE SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO SIGNIFICANT PAIN AND DISCOMFORT, TIGHTNESS, POPPING, AND SNAPPING OF THE KNEE, MOBILITY IMPAIRMENT, AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE. 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 MULTI-DISTRICT 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 MULTI-DISTRICT 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 T

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

  MAUDE report 17741230 ↗
• InjurySep 8, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN OTHER ISSUE ON (B)(6) 2020). THE PATIENT PRESENTED IN 2022 AND FLEXION INSTABILITY AND RECALLED POLYETHYLENE INSERT; REVISION R TKA SCHEDULED. THE PATIENT WAS REVISED (B)(6) 2022. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO DEVICE, DEFINITELY NOT RELATED TO PROCEDURE. OUTCOME: RESOLVED ON (B)(6) 2022.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 17710322 ↗
• InjurySep 1, 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) 2020. APPROXIMATELY 2 YEARS AND 2 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 RIGHT TKA; RIGHT KNEE INSTABILITY WITH VARUS STRESS FINDINGS: THE QUAD WAS ADHERENT ANTERIORLY AND A QUADRICEPSPLASTY WAS REQUIRED TO FREE THE EXTENSOR MECHANISM. THE FEMORAL COMPONENT WAS WELL FIXED BUT INTERNALLY ROTATED. THE TIBIAL TRAY WAS IN SLIGHT VARUS, BUT THERE WAS A NOTICEABLE GAP AT THE CEMENT BONE INTERFACE CONCERNING FOR LOOSENING.

  Patient problems: Discomfort; Failure of Implant; Implant Pain; Joint Laxity; Joint effusion; Scar Tissue; Swelling/ Edema

  MAUDE report 17669343 ↗
• InjuryJul 13, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021 AND THEN APPROXIMATELY 1 YEAR 11 MONTHS LATER THEY EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2022. PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES. REVISION OPERATIVE REPORT OF (B)(6) 2022-PREOP DIAGNOSIS: MECHANICAL LOOSENING OF INTERNAL RIGHT KNEE PROSTHETIC JOIN, OSTEOLYSIS PERIARTICULAR STATUS POST KNEE REPLACEMENT, POLYETHYLENE WEAR, SYNOVITIS. PROCEDURE: THERE WAS AN EFFUSION. THERE WAS SYNOVITIS NOTED WITHOUT OBVIOUS SIGNS OF INFECTION. THE PATELLA WAS EXAMINED AND FOUND TO BE STABLE. THEY PERFORMED A PATELLOPLASTY LATERALLY. THE FEMORAL AND TIBIAL COMPONENTS WERE REMOVED WITH A SMALL AMOUNT OF CENTRAL BONE LOSS ON THE TIBIAL SIDE AROUND THE FLANGES AND NO BONE LOSS ON THE FEMORAL SIDE. IN PARTICULAR, IN THE POSTERIOR LATERAL REGION OF THE FEMUR THERE WAS AN OSTEOLYTIC LESION OF SIGNIFICANT SIZE WITH SCLEROTIC MARGINS CONSISTENT WITH OSTEOLYSIS. DEVICES WERE TRIALED AND THEN IMPLANTED. STERILE COMPRESSIVE DRESSING WAS APPLIED. THE PATIENT TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. T

  Patient problems: Joint effusion; Osteolysis; Synovitis

  MAUDE report 17318011 ↗
• InjuryJul 5, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT UNDERWENT RIGHT KNEE REPLACEMENT ON (B)(6) 2018. THEY ARE SCHEDULED TO UNDERGO RIGHT KNEE REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 5 YEARS 2 MONTHS AFTER THEIR INITIAL PROCEDURE. PATIENT CLAIMS TO HAVE SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO SIGNIFICANT PAIN AND DISCOMFORT, SWELLING, LIMITED MOBILITY, INABILITY TO BEND OR KNEEL, GAIT IMPAIRMENT, AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Insufficient Information; Pain; Swelling/ Edema

  MAUDE report 17256745 ↗
• InjuryMay 25, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT (B)(6) 2019. AFTER THE SURGERY THE PATIENT IS EXPERIENCING SIGNIFICANT PAIN, CLICKING AND TIGHTNESS IN THE RIGHT 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.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Pain

  MAUDE report 17005166 ↗
• InjuryMay 8, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2021. APPROXIMATELY 1 YEAR AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION. REVISION OP REPORT 8 MAY 2023/ K MCGUINNESS RECEIVED VIA LEGAL 13 APR 2023. POSTOPERATIVE DIAGNOSIS: LEFT KNEE ARTHROFIBROSIS WITH POLYETHYLENE WEAR AND OSTEOLYSIS. DUE TO A HIGH BMI (37) THERE WAS INCREASED TIME WAS NECESSARY FOR EXPOSURE, CLOSURE AND BALANCING. STERILE DRESSINGS WERE APPLIED.

  Patient problems: Emotional Changes; Osteolysis; Pain; Scar Tissue

  MAUDE report 16885980 ↗
• InjuryFeb 14, 2023Naturally 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 NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL LEFT TKA ON (B)(6) 2018 AND WAS IMPLANTED WITH THE DEVICE. THE DEVICE SUBSEQUENTLY BEGAN TO FAIL CAUSING PAIN AND NOISES. BECAUSE OF THE FAILURE OF THE DEVICE, PLAINTIFF HAS SUFFERED SIGNIFICANT AND CONTINUING PERSONAL INJURIES, INCLUDING GREAT PAIN, DIFFICULTY WALKING, AND SIGNIFICANTLY DECREASED MOBILITY, AND PLAINTIFF IS LIMITED IN HIS ACTIVITIES OF DAILY LIVING, REQUIRES PHYSICAL THERAPY, AND HAS INCURRED SUBSTANTIAL MEDICAL BILLS AND EXPENSES. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

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

  MAUDE report 16371927 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM EXACTECH TRULIANT KNEE CLINICAL STUDY THAT A 72 YO OBESE MALE HAD A LEFT TOTAL KNEE ARTHROPLASTY FOR PRIMARY OSTEOARTHRITIS, EXPERIENCED A RESECTION OF L TKA WITH PLACEMENT OF ARTICULATING ANTIBIOTIC SPACER. OUTCOME RESOLVED: (B)(6) 2022.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 16092590 ↗