Truliant 02-022-35-3509Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10885862304346), received between Sep 13, 2021 and Feb 17, 2026 — classified as 32 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (27 reports).

2 FDA recall records name this device's identifier, 2 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. Nov 21, 2023Class IIOpen, Classified

   Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

   Z-0585-2024 · Root cause: Packaging change control · Recall details · FDA record ↗

2. 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 33 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA. THE PATIENT COMPLAINED OF SEVER PAIN, A POSSIBLE LOOSE FEMUR, AND WAS REVISED TO A COMPETITOR'S PRODUCT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Discomfort; Osteolysis; Pain; Unspecified Tissue Injury

  MAUDE report 24367109 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 2 YEARS AND 10 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE SURGEON WASHED OUT AND SWITCHED THE POLY INSERT TO THE SAME SIZE 3.5X9MM PS POLY TO ADDRESS POSSIBLE JOINT INFECTION. 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: Unspecified Infection

  MAUDE report 24099478 ↗
• InjuryFeb 19, 2025Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2019. APPROXIMATELY 4 YEARS AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. PATIENT COMPLAINED OF PAIN. LOOSE FEMUR AND RECALLED POLY. 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 WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Implant Pain; Joint effusion

  MAUDE report 21412222 ↗
• InjuryFeb 5, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 30 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, AMBULATION DIFFICULTIES, JOINT LAXITY, PAIN, AND SWELLING/EDEMA. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 21315812 ↗
• InjuryNov 21, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 48 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. UDI: (B)(4). PRODUCT CODE: JWH. X-RAY: NO. OPERATIVE NOTES: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20748069 ↗
• InjuryNov 6, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 60 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND INCREASING RECURRENT KNEE EFFUSIONS. 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: Failure of Implant; Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 20619585 ↗
• InjuryOct 28, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA. PATIENT ID: (B)(6) + RIGHT KNEE. 7/24/2024: ADDITIONAL INFORMATION RECEIVED IN IN-BOX ON 7/24/2024. INDICATIONS FOR THE PROCEDURE: THIS IS A 56-YEAR-OLD FEMALE WHO HAD A RIGHT TOTAL KNEE ARTHROPLASTY. SHE DID WELL UNTIL ABOUT 4.5 YEARS POST TKA WHEN SHE STARTED HAVING INCREASING PAIN AND SWELLING IN THE KNEE. INFECTION WORKUP WAS NEGATIVE. SHE FAILED CONSERVATIVE MANAGEMENT INCLUDING ANTI-INFLAMMATORIES, PHYSICAL THERAPY, GAIT ASSISTANCE AND ACTIVITY MODIFICATION. PREOPERATIVE AND POSTOPERATIVE DIAGNOSES INDICATED A FAILED RIGHT TOTAL KNEE ARTHROPLASTY SECONDARY TO PREMATURE POLYETHYLENE WEAR FROM A RECALLED POLYETHYLENE INSERT AND ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. DESCRIPTION OF PROCEDURE: THERE WAS POLYETHYLENE SYNOVITIS IN THE SUPERIOR ASPECT OF THE KNEE. I DID DEBRIDEMENT OF THE SYNOVIAL TISSUE WITH THE POLYETHYLENE DEBRIS AND SENT A SAMPLE OF THIS FOR CULTURE. THERE WERE NO SIGNS OF INFECTION OR PURULENCE. I CLEARED OFF THE SCAR TISSUE FROM AROUND THE PATELLAR BUTTON. THERE WAS FLATTENING AND WEAR OF THE LATERAL FACET AS WELLS AS A GOUGE OUT OF THE MEDIAL SIDE. I THEREFORE DECIDED TO EXCHANGE IT. I USED A THIN SAW BLADE TO REMOVE THE PREVIOUS PATELL

  Patient problems: Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 20547770 ↗
• InjuryAug 26, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL LEFT TKA, THE 48 Y/O FEMALE PATIENT COMPLAINED OF PAIN. THE PATIENT HAD A REVISION DUE TO 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. IMAGES AND X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO RECALL HOSPITAL WILL NOT RELEASE.

  Patient problems: Joint effusion; Osteolysis; Pain

  MAUDE report 20064077 ↗
• InjuryAug 23, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE - USA PATIENT ID: (B)(6) RELATED CASE: (B)(4). IT WAS REPORTED THAT APPROXIMATELY 74 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. 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. (B)(6) - 02-022-35-3511 - TRULIANT TIB IMP PS INSERT SZ 3.5 11MM. SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K170240.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Emotional Changes; Implant Pain; Joint Laxity; Swelling/ Edema; Synovitis

  MAUDE report 20057549 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS 72 Y/O FEMALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 3 YEARS 2 MONTHS POST OP. PATIENT COMPLAINED OF PAIN. LOOSE FEMUR AND RECALLED POLY. 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: Pain

  MAUDE report 19932168 ↗
• InjuryJul 2, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 17 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 19654115 ↗
• InjuryJun 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 30 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, AND CHRONIC PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 19616853 ↗
• InjuryJun 12, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 40 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; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19518393 ↗
• InjuryJun 3, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 56 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, INSTABILITY, POPPING, DISCOMFORT, AND LIMITED MOBILITY. 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; Joint Laxity; Pain

  MAUDE report 19453310 ↗
• InjuryMay 17, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 51 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19346453 ↗
• InjuryMay 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL SHORT FORM THAT APPROXIMATELY 74 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY NEED A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 19281658 ↗
• InjuryMay 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 61 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, TISSUE LOSS, AND BONE LOSS. 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

  MAUDE report 19261474 ↗
• InjuryMay 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 37 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE FOR POLYETHYLENE WEAR AND OTHER UNSPECIFIED ISSUES. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19258820 ↗
• InjuryJan 8, 2024Mechanical Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2021. APPROXIMATELY 1 YEAR 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 13 OCT 2022 DIAGNOSIS: RIGHT KNEE FAILURE FROM INFLAMMATORY RESPONSE TO NICKEL, MECHANICAL ALIGNMENT DIFFERING FROM NATIVE ANATOMIC ALIGNMENT LIMITING FLEXION AND EXTENSION. AT INTRA-OPERATIVE INSPECTION, THE RIND OF SCAR TISSUE SURROUNDING THE IMPLANT WAS CONFIRMED AND COMPLETE SYNOVECTOMY PERFORMED. THE PATIENT WAS REMOVED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Arthrofibrosis; Failure of Implant; Hypersensitivity/Allergic reaction; Inflammation; Loss of Range of Motion; Pain; Scar Tissue; Synovitis

  MAUDE report 18463189 ↗
• MalfunctionNov 29, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AS REPORTED, DURING SURGICAL USE, WHEN THE STAFF OPENED THE 3.5-9MM PS INSERT, THEY FOUND THAT A 5-9MM WAS INSIDE. A PS INSERT 3.5-10MM WAS INSERTED. THERE WAS NO BREAKAGE OF DEVICE. THERE WAS A GREATER THAN FIVE MINUTES SURGICAL DELAY; HOWEVER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF DELAY. IMAGES RECEIVED. THE DEVICE WILL BE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234476 ↗
• InjuryJul 20, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD BILATERAL KNEE REPLACEMENT ON (B)(6) 2017. THERE HAS BEEN NO REPORT OF REVISION SURGERY, OR PLAN/SCHEDULED FOLLOW UP NOTED. THE PATIENT CLAIMS TO HAVE SUFFERED AND CONTINUE TO SUFFER PERMANENT AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; SWELLING; INSTABILITY; GAIT IMPAIRMENT; DIFFICULTY ASCENDING AND DESCENDING STAIRS; 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: Ambulation or Postural Difficulties; Discomfort; Insufficient Information; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 17360462 ↗
• InjuryJul 18, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6), 2021. THEY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6), 2023, APPROXIMATELY 1 YEAR 3 MONTHS AFTER THEIR INITIAL PROCEDURE. (B)(6), 2023 OP REPORT STATES THAT THERE WAS OBVIOUS EVIDENCE OF OXIDATION OF THE POLYETHYLENE WITH YELLOW DISCOLORATION. THERE WAS ALSO PITTING NOTED IN BOTH THE MEDIAL AND LATERAL MID PORTION OF THE POLYETHYLENE. THERE WAS NO EVIDENCE OF ANY LOOSENING OF THE ACTUAL COMPONENTS. IT WAS ALSO NOTED THAT THE POLYETHYLENE HEAD OF THE PATELLA HAD SOME LATERAL EDGE WEAR AND UPON FURTHER INSPECTION, IT APPEARED THAT THE BUTTON WAS PLACED MEDIAL AND IT WAS A SMALL BUTTON AND THERE WAS STILL RESIDUAL PATELLA. THE SURGEON NOTED IT LOOKED LIKE THE PATELLA DURING FLEXION AND EXTENSION, THE LATERAL FEMORAL CONDYLE WAS RIDING ON THE EDGE OF THE PATELLA AND WAS TRACKING ABNORMALLY RESULTING IN ABNORMAL PATELLA WEAR ON THE LATERAL EDGE OF THE PATELLA. THE PATIENT WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. 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

  Patient problems: Failure of Implant; Implant Pain; Joint Laxity

  MAUDE report 17346970 ↗
• InjuryJul 17, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  REVISION SURGICAL PROCEDURE APPROXIMATELY 2 YEARS 2 MONTHS POST INITIAL IMPLANT. PREOPERATIVE DIAGNOSES: FAILED RIGHT TOTAL KNEE ARTHROPLASTY SECONDARY TO PREMATURE POLYETHYLENE WEAR FROM A RECALLED POLYETHYLENE INSERT AND ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. REVISION RIGHT. TOTAL KNEE ARTHROPLASTY OF FEMORAL, TIBIAL, AND PATELLAR COMPONENTS. PATIENT WAS REVISED TO COMPETITOR'S IMPLANTS. INFECTION WORK-UP WAS NEGATIVE. THERE WAS SOME EARLY POLYETHYLENE SYNOVITIS, BUT NO SIGNS OF INFECTION OR PURULENCE. THERE WAS EARLY WEAR OF THE PATELLAR BUTTON ON THE LATERAL FACET WITH FLATTENING, IT WAS EXCHANGED. ON GROSS INSPECTION OF THE TIBIAL INSERT, THERE WERE NO OBVIOUS SIGNS OF SIGNIFICANT WEAR, THERE WERE A COUPLE OF AREAS OF SOME PINNING. THERE WAS FAILURE OF BONY INGROWTH FOR THE FEMORAL COMPONENT, IT WAS REMOVED. TIBIAL COMPONENT WAS REMOVED. TILE PATIENT WAS AWOKEN FROM ANESTHESIA AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. NO COMPLICATIONS. DEVICE WILL NOT BE RETURNED. NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION REPORTED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Emotional Changes; Insufficient Information; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 17332905 ↗
• InjuryJun 20, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 5 YEARS POST OP INITIAL LEFT TKA, THIS 59 Y/O MALE PATIENT WAS REVISED DUE TO INSTABILITY. FEMUR, LINER AND PATELLA WERE EXCHANGED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS PROVIDED, UNABLE TO OBTAIN. NO PRODUCT RETURN - WITH LAWYER.

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

  MAUDE report 17164934 ↗
• InjuryApr 19, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE (B)(6) LK REV. RELATED (B)(4). AS REPORTED VIA LEGAL DOCUMENTATION, ON (B)(6) 2020, THE PATIENT UNDERWENT A TOTAL LEFT KNEE REPLACEMENT SURGERY AND WAS IMPLANTED WITH A NOW-RECALLED EXACTECH TRULIANT DEVICE IN HER LEFT KNEE. FOLLOWING THE SURGERY, THE PATIENT BEGAN EXPERIENCING INCREASING PAIN, BUCKLING, SWELLING, AND INFLAMMATION. THESE SYMPTOMS IMPACTED THEIR MOBILITY, RESULTING IN A SEVERE LIMP. THEY ALSO EXPERIENCED A CONSTANT SENSATION OF THE PARTS IN HER KNEES SHIFTING. IN (B)(6) 2022, THE PATIENT RECEIVED A RECALL LETTER REGARDING THE TRULIANT DEVICES THAT WERE IMPLANTED IN HER. ON (B)(6) 2022, SHE REPORTED TO HER PHYSICIAN WITH COMPLAINTS OF WORSENING PAIN AND SWELLING OF HER KNEES, AND INCREASING EPISODES OF BUCKLING. HER PHYSICIAN EXPLAINED THAT ¿ISSUES WITH FEMORAL LOOSENING¿ OF THE RECALLED IMPLANTS ARE ¿NOT EASILY SEEN ON XRAYS,¿ BUT THAT HE SUSPECTED ¿[SHE] IS LIKELY DEALING WITH LOOSE FEMORAL COMPONENTS AS WELL AS POSSIBLY SYNOVITIS RELATED TO EARLY POLYETHYLENE WEAR DUE TO THE RECALLED INSERTS.¿ DUE TO WORSENING PAIN, SWELLING, INSTABILITY, AND ¿FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO A RECALLED POLYETHYLENE INSERT AND ASEPTIC LOOSENING OF THE FE

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

  MAUDE report 16772746 ↗