Truliant 02-022-35-3013Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862304292), received between Jun 7, 2022 and Oct 11, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2024Naturally Worn; Naturally Worn

  LEGAL CASE: (B)(6). RELATED CASE: (B)(4). AS REPORTED VIA LEGAL DOCUMENTATION, ON OR ABOUT ON (B)(6) 2020, THIS PATIENT UNDERWENT REVISION OF HER RIGHT KNEE DUE TO IMPLANT LOOSENING AND SIGNIFICANT SYNOVITIS. ON OR ABOUT ON (B)(6) 2022, APPROXIMATELY 2 YEARS AND 6 MONTHS AFTER THEIR FIRST REVISION SURGERY, THE PATIENT UNDERWENT ANOTHER REVISION SURGERY OF HER RIGHT KNEE DUE TO MECHANICAL FAILURE. DURING THE REVISION SURGERY, THE SURGEON NOTED THAT THERE WAS "LARGE EFFUSION WITH EXTENSIVE POLY WEAR SYNOVITIS THROUGHOUT THE KNEE" AND THAT THERE WAS "MEDIAL TIBIAL OSTEOLYSIS WITH AREAS OF BONY EROSION" THE SUBSEQUENT POST-OPERATIVE DIAGNOSIS CONFIRMED THAT THE PATIENT'S RIGHT TOTAL KNEE ARTHROPLASTY FAILED DUE TO SIGNIFICANT LOOSENING, WHICH IS RELATED TO THE FAILURE IN THE POLYETHYLENE. 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. EBI INITIAL SURGERY ATTACHED. HISTORICAL RECORD & SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. 5727847 02-010-06-0330 - LOGIC C

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort

  MAUDE report 20429036 ↗
• InjuryJun 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 10 MONTHS AFTER A TOTAL 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 19510988 ↗
• InjuryApr 8, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 6 YEARS AND 2 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO DEVICE INFORMATION PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 19057824 ↗
• InjurySep 27, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2018. APPROXIMATELY 3 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. THE PATIENT EXPERIENCED PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS. 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. (B)(4), AND PENDING IN THE (B)(6). 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 THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTI DISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF A

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

  MAUDE report 17823582 ↗
• InjuryAug 31, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Unstable; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2018. APPROXIMATELY 3 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2021. 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) 2021: DIAGNOSIS: RIGHT TOTAL KNEE PROSTHETIC INSTABILITY. INSPECTION OF THE FEMORAL AND TIBIAL METAL IMPLANTS WAS DONE AFTER REMOVAL FINDING NO EVIDENCE OF EROSION OR LOOSENING AT ANY POSITION. A 17 MM POLYETHYLENE TRIAL WAS SUBSTITUTED FINDING THE INSTABILITY TO BE COMPLETELY ATTENDED. THE PATIENT AWAKENED AND RETURNED TO THE RECOVERY ROOM WITHOUT COMPLICATIONS.

  Patient problems: Insufficient Information; Joint Laxity; Pain; Scar Tissue

  MAUDE report 17663270 ↗
• InjuryJul 27, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY 1 YEAR POST INITIAL RIGHT TKA, THIS FEMALE PATIENT UNDERWENT A REVISION SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15112876 ↗
• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY TWO YEARS POST INITIAL RIGHT TKA, SURGEON PREFORMED A POLY SWAP OF A (B)(6) Y/O MALE PATIENT DUE TO INSTABILITY. 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 PRODUCT IS NOT AVAILABLE FOR RETURN.

  Patient problems: Failure of Implant

  MAUDE report 14622648 ↗