Truliant 02-020-11-0215Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862314406), received between Jun 14, 2023 and Sep 30, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 reports).

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.

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 30, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA (MDL NO. (B)(4)). PATIENT ID: (B)(6). RELATED (B)(4). AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2019. APPROXIMATELY 3 YEARS AND 2 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 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. 02-022-35-1509 - TRULIANT TIB IMP PS INSERT SZ 1.5, 9MM. SN: (B)(6). CONCOMITANT DEVICES: (B)(4) A10012 - GPS IMPLANT KIT V2. (B)(4) 02-012-60-1425 - TRU STEM EXT 14MM X 25MM. (B)(4) 02-020-11-0215 - TRULIANT PS CEM FEM PS CEM LEFT SZ 1.5. (B)(4) 02-022-45-1515 - TRULIANT TIB FIT TRAY CEM SZ 1.5F / 1.5T. (B)(4) 200-02-29 - THREE PEG PATELLA 29MM. (B)(4) 204-70-00 - TIBIAL STEM EXT. SCREW. 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 EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDIST

  Patient problems: Osteolysis

  MAUDE report 20332542 ↗
• InjurySep 18, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THIS 63 Y/O FEMALE PATIENT'S LEFT KNEE WAS REVISED. THE INITIAL PROCEDURE THE IMPLANT BECAME GROSSLY LOOSE. PATIENT WAS REVISED TO A CC TRULIANT FEMORAL COMPONENT WITH A STEM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY. PRODUCT NOT RETURNING - IMPLANT WAS DISCARDED DURING CLEANING OF INSTRUMENTS. X-RAY ATTACHED. UNABLE TO OBTAIN PHOTOS.

  Patient problems: Failure of Implant

  MAUDE report 17765347 ↗
• InjuryJun 14, 2023Loosening of Implant Not Related to Bone-Ingrowth; Lack of Effect; Loosening of Implant Not Related to Bone-Ingrowth; Lack of Effect

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018. THEY SUBSEQUENTLY HAD LEFT KNEE REVISION ON (B)(6) 2022, APPROXIMATELY 3 YEARS 11 MONTHS AFTER THEIR INITIAL SURGERY. POSTOPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND A RECALLED TIBIAL INSERT. RADIOGRAPHS DID NOT SHOW ANY OBVIOUS SIGNS OF WEAR OR LOOSENING. THE PATIENT HAD SIGNIFICANT SCAR TISSUE WITHIN THE JOINT AND SOME SYNOVITIS, BUT NO SIGNS OF INFECTION OR PURULENCE. THE PATELLAR BUTTON WAS FOUND TO BE WELL FIXED AND IN GOOD CONDITION. UPON REMOVAL OF THE INSERT, THERE WERE NO SIGNS OF WEAR OR DAMAGE TO THE INSERT. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Loss of Range of Motion; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 17130934 ↗