Truliant 02-022-35-3009Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10885862304254), received between Dec 26, 2019 and Apr 10, 2026 — classified as 48 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-0023-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2026Naturally Worn

  IT WAS REPORTED THAT A 60YEAR OLD MALE PATIENT, WHO WAS HAD AN INITIAL LEFT KNEE REPLACEMENT ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 4 YEARS 5 MONTHS POST THE INITIAL IMPLANT PROCEDURE. THE SURGEON REVISED A SIZE 3 LEFT FEMUR WHICH WAS LOOSE AND PS SIZE 3/9MM INSERT TO A LEFT SIZE 3 CONSTRAINED CONDYLAR FEMUR WITH A 14X120 STEM AND A CONSTRAINED SIZE 3/9MM INSERT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WERE NOT ABLE TO BE OBTAINED BY THE REP FOR RETURN.

  Patient problems: Discomfort; Muscle Weakness/Atrophy; Pain

  MAUDE report 24839501 ↗
• InjuryMar 23, 2026Unstable

  IT WAS REPORTED THAT A FEMALE PATIENT, WHO HAD A LEFT TKA, UNDERWENT A REVISION PROCEDURE. THE SURGEON CONTACTED THE PATIENT REQUESTING THEY GET A POLY SWAP. THE PREVIOUSLY IMPLANTED POLY WAS EXPLANTED AND REPLACED WITH A DIFFERENT SIZE. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN AS THE HOSPITAL WOULD NOT RELEASE THEM. NO DEVICE IMAGES WERE ABLE TO BE OBTAINED. NO FURTHER INFORMATION.

  Patient problems: Joint Laxity

  MAUDE report 24671208 ↗
• InjuryMay 27, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS AND 9 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT COMPLAINED OF PAIN AND WAS REVISED DUE TO A LOOSE FEMUR AND BAD POLY. 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. ADDITIONAL INFORMATION RECEIVED VIA LEGAL NOTIFICATION NOTED THAT THE PATIENT UNDERWENT THE REVISION PROCEDURE TO ADDRESS WEAR, LOOSENING, PAIN, STIFFNESS, SWELLING, DISCOMFORT, WEAKNESS, AND INSTABILITY.

  Patient problems: Aseptic loosening; Discomfort; Joint Laxity; Muscle Weakness/Atrophy; Pain; Swelling/ Edema

  MAUDE report 22087785 ↗
• InjuryMar 6, 2025Unstable; Unstable

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED. SURGEON REVISED THE POLY DUE TO THE UNSTABLE KNEE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 21536374 ↗
• InjuryJan 27, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4.5 YEARS POST INITIAL RIGHT SIDE TKA, THE 55 Y/O FEMALE PATIENT COMPLAINT OF PAIN AND HAD A REVISION DUE TO RECALLED POLY AND LOOSE FEMUR. PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PHOTOS AND X-RAY RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO RECALL HOSPITAL WILL NOT RELEASE IMPLANTS. CONCOMITANT PRODUCTS: - TRULIANT TIB IMP PS INSERT SZ 3 9MM (CAT# 02-022-35-3009 / SERIAL# (B)(6) - SERIAL NUMBER NOT AFFECTED BY RECALL) COMPLAINT INVESTIGATION FINDINGS: COMPLAINT INVESTIGATION FINDINGS: THE REVISIONS REPORTED IN (B)(4) WAS LIKELY THE RESULT OF INSUFFICIENT BONDS BETWEEN THE FEMORAL COMPONENTS AND THE BONES AND/OR PATIENT RELATED CONDITIONS, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. THE MOST PROBABLE ROOT CAUSE ASSOCIATED WITH THE REPORTED EVENT OF ¿LOOSENING - FEMORAL¿ IS ASSOCIATED WITH WEAKENED INTEGRATION OF THE FEMORAL COMPONENT AT THE BONE-IMPLANT INTERFAC

  Patient problems: Pain

  MAUDE report 21243890 ↗
• InjuryDec 26, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4.5 YEARS POST INITIAL BILATERAL TKA, THE 55 Y/O FEMALE PATIENT COMPLAINED OF PAIN. PATIENT HAD A LEFT KNEE REVISION DUE TO RECALLED POLY AND LOOSE FEMUR. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL WILL NOT RELEASE RECALLED IMPLANTS. RIGHT KNEE REVISION REPORTED UNDER MDR # 1038671-2023-01973.

  Patient problems: Pain

  MAUDE report 21021096 ↗
• InjuryNov 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 63 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

  MAUDE report 20632834 ↗
• InjuryNov 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 82 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, LEFT KNEE REVISION PENDING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20632293 ↗
• InjurySep 20, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA ((B)(4)). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 26 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SIGNIFICANT PAIN AND DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, SOFT TISSUE DAMAGE, BONE LOSS, AND OTHER INJURIES PRESENTLY UNDIAGNOSED, MENTAL AND EMOTIONAL DISTRESS. 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: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Loss of Range of Motion; Osteolysis; Pain

  MAUDE report 20270940 ↗
• InjurySep 13, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4)). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 44 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, SWELLING, INSTABILITY, OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. (B)(6) 02-022-35-3009 - TRULIANT TIB IMP PS INSERT SZ 3 9MM. ***SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES CONTAIN EVOH AND WAS NOT AFFECTED BY THE RECALL.

  Patient problems: Insufficient Information; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20217680 ↗
• InjuryAug 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 15 MONTHS AFTER A RIGHT 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 20027439 ↗
• InjuryAug 21, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 11 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, TISSUE AND BONE LOSS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20020721 ↗
• InjuryAug 20, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 61 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20002414 ↗
• InjuryAug 20, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 76 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, PAIN, STIFFNESS, SWELLING, DISCOMFORT, WEAKNESS AND INSTABILITY. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO ADDITIONAL INFORMATION IS AVAILABLE

  Patient problems: Discomfort; Joint Laxity; Muscle Weakness/Atrophy; Pain; Swelling/ Edema

  MAUDE report 20000742 ↗
• InjuryAug 14, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 46 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEARPAIN, SUFFERING, LOSS OF MOBILITY, LOSS OF ENJOYMENT OF LIFE. KNEE REPLACEMENT CONTINUED TO FAIL RESULTING IN MANY FALLS, ONE OF WHICH CAUSE A FRACTURE ON HER SPINAL ROD. 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; Pain; Vertebral Fracture

  MAUDE report 19980641 ↗
• InjuryAug 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 35 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; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19932243 ↗
• InjuryJul 24, 2024Naturally Worn; Naturally Worn

  AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, APPROXIMATELY 3 YEARS, 7 MONTHS POST INITIAL TKA, PATIENT HAD A REVISION DUE TO POLYETHYLENE WEAR AND FEMORAL LOOSENING. ADDITIONAL INFORMATION RECEIVED FROM LEGAL BRIEF INDICATES THAT FOLLOWING THE SURGERY, PATIENT BEGAN EXPERIENCING WORSENING SYMPTOMS, PAIN, INSTABILITY, EFFUSION, AND ANTALGIC GATE. PATIENT¿S PHYSICIAN DISCUSSED WITH PATIENT HIS CONCERNS REGARDING EARLY OXIDATION OF HER RECALLED EXACTECH POLYETHYLENE INSERT AND SUSPECTED FEMORAL LOOSENING. PATIENT WAS DIAGNOSED WITH ¿FAILED TOTAL RIGHT KNEE REPLACEMENT¿ SECONDARY TO HER RECALLED TRULIANT DEVICE AND WAS INFORMED OF HER NEED FOR A FULL REVISION SURGERY. PATIENT WAS SCHEDULED FOR A RIGHT KNEE REPLACEMENT REVISION SURGERY AND THEN RESCHEDULED. PER THE EVENT INFORMATION PROVIDED THE REVISION OCCURRED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Joint effusion; Pain

  MAUDE report 19818934 ↗
• InjuryMay 22, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE ARTHROPLASTY ON (B)(6) 2020, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2024, APPROXIMATELY 3 YEARS, 6 MONTHS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 19374905 ↗
• InjuryMay 21, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 41 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR AND PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Insufficient Information

  MAUDE report 19367262 ↗
• InjuryMay 8, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 47 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN, SWELLING, INSTABILITY, METAPHYSEAL BONE DAMAGE, CANCELLOUS BONE LOSS, AND INFLAMED SYNOVIUM. OPERATIVE NOTE IN LEGAL SHORT FORM NOTED BONE LOSS AND 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; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 19268481 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 68 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2022, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 1 YEAR 11 MONTHS POST THE INITIAL PROCEDURE. REASON FOR THE REVISION WAS NOT REPORTED. THE POLY WAS SWAPPED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. NO EXPLANTED DEVICES ARE AVAILABLE FOR ANALYSIS. CHAIN OF COMMAND DUE TO THE RECAL,L THE HOSPITAL WILL NOT RELEASE THEM. A DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 19072399 ↗
• InjuryMar 5, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6)2022, APPROXIMATELY 4 YEARS, 5 MONTHS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 18841189 ↗
• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 68 YO FEMALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2018, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 5 YEARS 1 MONTH POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED TO THE SURGEON WITH A STIFF KNEE. THE POLY AND FEMUR WERE REPLACED DUE TO THE STIFFNESS. THE REPLACEMENT FEMUR COMPONENT WAS A COMPETITOR¿S DEVICE. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT HAD A SUCCESSFUL REVISION CASE. THE REVISION CASE TURNED OUT WELL. NO DEVICE RETURNS AVAILABLE. THE REP DOES NOT HAVE THE DEVICE BUT SENT PICTURES. X-RAY IMAGES WERE ALSO PROVIDED. NO PATIENT INFORMATION OR HISTORY WAS KNOWN. NO FURTHER INFORMATION.

  Patient problems: Ankylosis; Unspecified Musculoskeletal problem

  MAUDE report 18407195 ↗
• InjuryDec 12, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2018. APPROXIMATELY 4 YEARS AND 5 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 31 MAR 2023 DIAGNOSIS: FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO POLYETHYLENE WEAR FROM A RECALLED TIBIAL INSERT AND ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. "THERE WAS SYNOVITIS WITH EVIDENCE OF POLYETHYLENE DEBRIS IN THE GUTTERS. I RELEASED SOFT TISSUE SLEEVE OFF THE PROXIMAL MEDIAL TIBIA. I THEN BROUGHT THE KNEE INTO EXTENSION. I DEBRIDED THE SYNOVIAL TISSUE AND THE POLYETHYLENE SYNOVITIS USING BOVIE CAUTERY AND A RONGEUR. I THEN CLEARED OFF THE SCAR TISSUE FROM AROUND THE PATELLAR BUTTON. THERE WAS SOME DAMAGE TO THIS AS WELL. I THEREFORE DECIDED TO EXCHANGE IT. THE PREVIOUS TIBIAL INSERT WAS REMOVED WITH A 1/2-INCH OSTEOTOME. ON GROSS INSPECTION, THERE WERE NO OBVIOUS WEAR, THERE WAS A LITTLE BIT OF PITTING IN THE ARTICULAR SURFACE. I THEN USED THE D

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

  MAUDE report 18310110 ↗
• InjuryDec 5, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 3 YEARS POST OP INITIAL RIGHT TKA, THIS 67 Y/O FEMALE PATIENT WAS REVISED. PATIENT HAD RECALLED LINER AND LOOSE FEMUR. SURGEON REPLACED FEMUR AND POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18265788 ↗