Truliant 02-022-35-3511Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862304360), received between Mar 6, 2023 and Oct 1, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Naturally Worn” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 1, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 15 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, JOINT PAIN, JOINT SWELLING AND STIFFNESS, LIMITED RANGE OF MOTION, LOSS OF MOBILITY, REVISION SURGERY AND INSTABILITY. 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; Inflammation; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 20345701 ↗
• InjuryJun 19, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH A TRULIANT DEVICE ON THE RIGHT KNEE, WITH NO REVISION SURGERY REPORTED. IT IS STATED THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS 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: Discomfort; Pain

  MAUDE report 19570905 ↗
• InjuryApr 2, 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 A PATIENT HAD A TOTAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2020 AND THEN APPROXIMATELY 3 YEARS 1 MONTH LATER EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023. REVISION OPERATIVE REPORT OF (B)(6) 2023- POSTOPERATIVE DIAGNOSIS: MECHANICAL FAILURE RIGHT TOTAL KNEE ARTHROPLASTY WITH INSTABILITY PROCEDURE PERFORMED: REVISION RIGHT TOTAL KNEE ARTHROPLASTY FEMORAL AND TIBIAL COMPONENTS. PATIENT REVISED TO COMPETITOR'S DEVICES. FINDINGS: NO CLINICAL EVIDENCE OF INFECTION, HISTOLOGICAL ANALYSIS DEMONSTRATED NO ACUTE INFLAMMATION, LIGAMENTOUS AND FLEXION INSTABILITY, PREDOMINANTLY LATERALLY, WELL FIXED FEMORAL, TIBIAL, AND PATELLAR COMPONENTS, POLY WEAR WITH GROSS INSTABILITY. THE PATIENT WAS AWAKENED AND SENT TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO COMPLICATIONS. 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; Pain; Scar Tissue

  MAUDE report 19018749 ↗
• InjurySep 20, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2017. THE DEVICE HAS NOT BEEN EXPLANTED. 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 COMPLAINT IN A COORDINATED ACTION IN ALACHUA COUNTY WITH MASTER CASE NO. (B)(6). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 17782819 ↗
• InjuryAug 16, 2023Unstable; Detachment of Device or Device Component; Naturally Worn; Unstable; Detachment of Device or Device Component; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2018. APPROXIMATELY 4 YEARS AND 10 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 POLYETHYLENE COMPONENT, RIGHT TOTAL KNEE DUE TO WEAR WITH LOOSE FEMORAL COMPONENT. FINDINGS: THERE WAS FOUND TO BE A CLEAN WOUND WITH CLEAR SYNOVIAL JOINT FLUID. THERE WAS EVIDENCE OF POLYETHYLENE WEAR WITH ENCAPSULATED POLYETHYLENE DEBRIS WITHIN THE SYNOVIUM AND A COMPLETE SYNOVECTOMY WAS PERFORMED. THERE WAS FOUND TO BE A LOOSE FEMORAL COMPONENT FROM THE CEMENT MANTLE AND THERE WAS AN UN-RESURFACED PATELLA DUE TO A THIN, NATIVE, WORN PATELLA FROM PREVIOUS SURGERY.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Inflammation; Joint Laxity; Osteolysis; Pain; Scar Tissue; Synovitis

  MAUDE report 17557618 ↗
• 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 17360292 ↗
• InjuryJun 16, 2023Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020 AND THEN APPROXIMATELY 1 YEAR, 3 MONTHS LATER WAS SURGICALLY REVISED ON (B)(6) 2021. 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: Insufficient Information

  MAUDE report 17148337 ↗
• InjuryMay 5, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD RIGHT KNEE REPLACEMENT ON (B)(6) 2017. PATIENT HAD RIGHT KNEE REVISION ON (B)(6) 2023, APPROXIMATELY 5 YEARS 3 MONTHS AFTER THEIR INITIAL REPLACEMENT. POSTOPERATIVE DIAGNOSIS: FAILED RIGHT TOTAL KNEE POLYETHYLENE DUE TO PREMATURE WEAR AND POLYETHYLENE RECALL, AS WELL AS LOOSE FEMORAL COMPONENT. THERE WAS FOUND TO BE VISIBLE EVIDENCE OF POLYETHYLENE WEAR WITH ENCAPSULATED POLYETHYLENE DEBRIS OF THE SYNOVIUM. THERE WAS FOUND TO BE A LOOSE FEMORAL COMPONENT AND WELL-FIXED TIBIAL AND PATELLAR COMPONENTS. 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

  MAUDE report 16880770 ↗
• InjuryMar 6, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL BILATERAL KNEE REPLACEMENT SURGERY ON (B)(6) 2018 AND WAS IMPLANTED WITH A TRULIANT POSTERIOR STABILIZED TIBIAL INSERT IN BOTH HIS RIGHT AND LEFT KNEES. FOLLOWING THE SURGERY, PLAINTIFF BEGAN EXPERIENCING INCREASING CHRONIC KNEE PAIN IN BOTH KNEES THAT STEADILY BECAME WORSE. PLAINTIFF ALSO REPORTED STIFFNESS, SWELLING, INFLAMMATION, NONRECIPROCAL GAIT, AND AN INABILITY TO USE STAIRS WITHOUT EXPERIENCING SEVERE PAIN IN BOTH KNEES. PLAINTIFF¿S PHYSICIAN INFORMED PLAINTIFF THAT DUE TO EXACTECH¿S RECALL OF PLAINTIFF¿S KNEE IMPLANT, PLAINTIFF ¿MAY BE DEALING WITH SOME EARLY WEAR AND INFLAMMATORY RESPONSE INSIDE BOTH KNEES¿ AND MAY BE EXPERIENCING ¿LOOSE FEMORAL COMPONENTS WITH THE BONDING OF THE FEMUR FROM THE CEMENT MANTLE.¿ PLAINTIFF¿S PHYSICIAN SUGGESTED REVISION SURGERY AND EXPLAINED THAT THE SURGERY ¿WOULD BE A FULL REVISION IF [PLAINTIFF] IS FOUND TO HAVE A LOOSE FEMORAL COMPONENT AT THE TIME OF SURGERY.¿ PLAINTIFF WAS DIAGNOSED WITH ¿FAILED [LEFT] TKA DUE TO A RECALLED POLYETHYLENE INSERT AND POSSIBLE FEMORAL LOOSENING.¿ PLAINTIFF¿S PHYSICIAN RECOMMENDED UNDERGOING A LEFT KNEE REVISION SURGERY FIRST DUE TO PL

  Patient problems: Implant Pain

  MAUDE report 16486433 ↗