Truliant 02-022-51-3509Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885862307699), received between Jun 14, 2022 and Mar 19, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Naturally Worn” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED. PATIENT HAD A POLY SWAP THAT WAS SECONDARY TO AN INFECTION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21643195 ↗
• InjuryOct 1, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 28 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. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0023-2022.

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

  MAUDE report 20343814 ↗
• InjuryJul 2, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 61 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE A FUTURE REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655224 ↗
• InjuryMay 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 29 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR. THE PATIENT HAS REPORTED SEVERE PAIN, SWELLING, AND INSTABILITY. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 19262645 ↗
• InjuryNov 16, 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)2018. APPROXIMATELY 4 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 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 (NGG) (MMH), 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 PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

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

  MAUDE report 18148101 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY 2 YEARS POST OP INITIAL RIGHT TKA, THIS MALE PATIENT WAS REVISED. A THICKER 13 CRC WAS IMPLANTED AND THE PATELLA WAS RESURFACED WITH A 38MM. NO ISSUES WITH SURGERY. EXPLANTS NOT AVAILABLE. NO FURTHER INFORMATION.

  Patient problems: Failure of Implant; Pain; Synovitis

  MAUDE report 17189916 ↗
• InjuryMay 15, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A 67 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON AN UNKNOWN DATE, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023. THE PATIENT WAS COMPLAINING OF PAIN. THEY HAD AN EXTENSIVE AMOUNT OF SWELLING TYPICALLY WORSE TOWARDS THE END OF THE DAY THAT DID NOT IMPROVE BY MORNING. ON EXAM, THE PATIENT HAD A SEVERE EFFUSION, AND THE RADIOGRAPH SUGGESTED THAT THE MEDIAL COMPARTMENT OF THE TKA WAS NARROWER THAN THE LATERAL COMPARTMENT. GIVEN THE PATIENT'S SYMPTOMS, AS WELL AS THE SUBTLE CHANGES WITH REGARDS TO THE THICKNESS OF THE POLYETHYLENE ON THE TKA, THE PATIENT WAS SENT TO HAVE A CT FOR FURTHER EVALUATION. THE CT CONFIRMED THAT THE POLYETHYLENE HEIGHT IS SLIGHTLY DECREASED WITH REGARD TO THE MEDIAL COMPARTMENT WHEN COMPARED TO THE LATERAL. FOLLOWING BEING EXAMINED, THE DECISION WAS MADE TO REVISE THE POLYETHYLENE GIVEN THE PATIENT'S SYMPTOMS AND CT FINDINGS. THE SURGICAL APPROACH WAS MADE THROUGH THE EXISTING MEDIAL PARAPATELLAR TKA INCISION. NO SYNOVITIS WAS NOTED IN THE SOFT TISSUE SUPERFICIAL TO THE ARTHROTOMY. WHEN THE ARTHROTOMY WAS MADE COPIOUS AMOUNTS OF DARK STRAW-COLORED JOINT FLUID POURED OUT OF THE JOINT. NO SYNOVITIS WAS NOTED ALONG THE PERIOSTEUM NOR WA

  Patient problems: Implant Pain; Joint effusion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 16936168 ↗
• InjurySep 13, 2022Adverse 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 FEMALE PATIENT, INITIALLY IMPLANTED ON THE RIGHT KNEE ON (B)(6) 2020, UNDERWENT A REVISION DUE TO PAIN. THE SURGEON REMOVED THE INSERT AND STATED THERE WAS NO SIGNIFICANT POLY WEAR. THE ARTICULATION SURFACE APPEARED SMOOTH WITH NO DAMAGE. THE ORIGINAL INSERT WAS 9MM BUT THE 10MM TRIAL WAS FOUND TO BE STABLE WITH GOOD ROM SO A NEW 10MM CRC WAS IMPLANTED. THE SURGEON ALSO RESURFACED THE PATELLA WITH A STANDARD 35MM 3 PEG PATELLA AND STATED THAT THE PATIENT¿S PAIN WAS POSSIBLY FROM THE PATELLA. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Implant Pain; Pain

  MAUDE report 15415003 ↗
• InjurySep 9, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL TKA ON (B)(6) 2018. THE PATIENT PRESENTED TO THE CLINIC WITH PAIN. MRI SHOWED SYNOVITIS. REVISION SURGERY WAS PERFORMED ON (B)(6) 2022. THE SURGEON RELEASED THE SCAR TISSUE AROUND THE ANTERIOR KNEE. HE NOTED ONLY MILD SURFACE CHANGES TO THE INSERT. A NEW 9MM INSERT WAS IMPLANTED WITH GOOD ROM AND STABILITY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. EXPLANTS ARE NOT AVAILABLE WITHOUT PATIENT RELEASE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Adhesion(s); Failure of Implant; Pain; Synovitis

  MAUDE report 15391230 ↗
• InjuryAug 25, 2022Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT A FEMALE PATIENT, RIGHT KNEE INITIALLY IMPLANTED ON (B)(6) 2020, PRESENTED TO THE CLINIC WITH PAIN AND INSTABILITY AND WAS REVISED APPROXIMATELY 2 YEARS POST THE INITIAL PROCEDURE. THE SURGEON NOTED THE POLY WAS NOT WORN DOWN SIGNIFICANTLY. THERE WAS SOME MILD PITTING IN LATERAL AREA. FLEXION INSTABILITY WAS NOTED WITH MEDIAL GAPPING, BUT EXTENSION WAS GOOD. RELEASES WERE PERFORMED TO EVEN OUT GAPS AND THICKER INSERT WAS IMPLANTED. THE KNEE WAS WELL BALANCED WITH A 13MM CRC INSERT. FLEXION INSTABILITY WAS SIGNIFICANTLY RESOLVED. SURGEON WAS HAPPY WITH RESULT AND PATIENT LEFT IN STABLE CONDITION.

  Patient problems: Failure of Implant; Joint Laxity; Muscle/Tendon Damage; Pain; Scar Tissue

  MAUDE report 15294108 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT RETURNED TO CLINIC WITH PAIN AND TIGHTNESS. THIS WEEK ON MONDAY THE PATIENT WAS REVISED AGAIN DUE TO PAIN AND TIGHTNESS. SURGEON NOTED NON COMPLIANCE WITH POST OP INSTRUCTIONS. THE INSERT WAS DROPPED FROM 15 TO 12MM AND ROM WAS SIGNIFICANTLY IMPROVED. IMPLANTS NOT AVAILABLE TO RETURN. NO FURTHER INFORMATION AVAILABLE. PATIENT LAST KNOWN TO BE IN STABLE CONDITION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15245404 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY THREE MONTHS POST INITIAL LEFT TKA, THE 54 Y/O PATIENT HAD A REVISION. THE POLY WAS EXCHANGED FOR A NEW ONE OF THE SAME SIZE DURING A SYNOVECTOMY. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 14684738 ↗