Truliant 02-022-44-5009Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862305442), received between Sep 24, 2022 and Sep 19, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. DEVICE HAS NOT BEEN EXPLANTED. THE PATIENT EXPERIENCES 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 MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Insufficient Information; Pain

  MAUDE report 17772772 ↗
• InjurySep 19, 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) 2019. APPROXIMATELY 3 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. THE PATIENT EXPERIENCES 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 MULTIDISTRICT 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 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 POL

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

  MAUDE report 17772372 ↗
• InjurySep 24, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT HAD A BILATERAL TKA ON (B)(6) 2013. THE PATIENT'S RIGHT KNEE WAS REVISED ON (B)(6) 2022 FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, INSTABILITY AND/OR COMPONENT LOOSENING. THE PATIENT EXPERIENCES DAILY PAIN AND DISCOMFORT IN HIS KNEES WHICH LIMITED AND CONTINUES TO LIMIT HIS ACTIVITIES OF DAILY LIVING AND IMPACTS HIS QUALITY OF LIFE.

  Patient problems: Failure of Implant

  MAUDE report 15476161 ↗