Truliant 02-020-11-0320Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862314529), received between Oct 29, 2019 and Mar 12, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 58 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, AMBULATION DIFFICULTIES, DISCOMFORT, IMPLANT PAIN, OSTEOLYSIS, AND SWELLING/EDEMA. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Implant Pain; Osteolysis; Swelling/ Edema

  MAUDE report 21585995 ↗
• InjuryJan 13, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 50 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, INSTABILITY, AND SYNOVITIS. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Synovitis

  MAUDE report 21141816 ↗
• InjuryOct 10, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA. IT WAS REPORTED THAT APPROXIMATELY 67 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS MASSIVE POLY WEAR. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. INDICATION: ASEPTIC LOOSENING IN THE SETTING OF MASSIVE POLY WEAR FROM RECALLED IMPLANT. PROCEDURE DESCRIPTION: IT WAS NOTED THAT THERE WAS HYPERTROPHIC AND METALLIC APPEARANCE OF THE SYNOVIUM. AN EXAMINATION OF THE POLYETHYLENE LINER REVEALED CATASTROPHIC FAILURE OF THE MEDIAL COMPARTMENT LEADING TO METAL ON METAL ARTICULATION. RETRACTORS WERE PLACED AND THE FEMORAL COMPONENT WAS REMOVED WITH MINIMAL BONE LOSS. NEXT THE TIBIA WAS PRESENTED ANTERIORLY AND A THIN CURVED OSTEOTOME WAS USED TO REMOVE THE TIBIAL COMPONENT. THIS AGAIN WAS PERFORMED WITH MINIMAL DIFFICULTY AND MINIMAL BONE LOSS. THERE WAS A SIGNIFICANT CAVITARY LESION IN THE PATELLA THAT WAS DEBRIDED WITH A RONGEUR AND CURETTE. THE PATIENT WAS TRANSFERRED TO PACU IN STABLE CONDITION.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Metal Related Pathology; Scar Tissue

  MAUDE report 20422056 ↗
• InjuryJul 17, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 5.5 YEARS POST INITIAL RIGHT SIDE TKA, THE 37 Y/O FEMALE PATIENT COMPLAINED OF PAIN. PATIENT HAD A REVISION DUE TO LOOSE FEMUR AND RECALLED POLY AND DUE TO RECALL SURGEON USED COMPETITOR'S DEVICE FOR REVISION. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY / PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAY AND IMAGES RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO RECALL HOSPITAL WILL NOT RELEASE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17333280 ↗
• InjuryDec 19, 2022Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA EXACTECH CLINICAL STUDY THAT THE 51-YEAR-OLD OVERWEIGHT CAUCASIAN FEMALE PATIENT EXPERIENCED ¿INSTABILITY¿ TOTAL RIGHT KNEE ARTHROPLASTY. THE DATE OF EVENT ONSET IS ON (B)(6) 2021. THE PATIENT IS DOING EXTREMELY WELL HOWEVER THE MECHANICAL NATURE OF HER PAIN WHICH PREVIOUSLY CONSISTS OF CREPITUS OVER HER RIGHT KNEE IS VERY EXCRUCIATING AND SHE WOULD LIKE TO PROCEED WITH AN ALTERNATIVE OPTION; RELUCTANT TO PROCEED WITH A CORTICOSTEROID INJECTION TO THE RISK FOR INFECTION AND HAVE INSTEAD OFFER HER THE OPPORTUNITY FOR INTRA-ARTICULAR ARTHROSCOPY TO DEBRIDE ANY SCAR TISSUE WHICH MAY BE PRESENT AND CAUSING A PAINFUL SENSATION. SHE HAS AGREED TO PROCEED ACCORDINGLY. ACTION TAKEN; RIGHT KNEE ARTHROSCOPY AND DEBRIDEMENT. THE PATIENTS LAST KNOWN OUTCOME IS RESOLVED ON (B)(6) 2021. NO ADDITIONAL INFORMATION.

  Patient problems: Crepitus; Discomfort; Implant Pain; Joint Laxity; Scar Tissue

  MAUDE report 16008245 ↗
• InjuryOct 4, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 3 YRS POSTOP THE INITIAL R TKA, THE (B)(6) Y/O FEMALE PATIENT WAS REVISED DUE TO PAIN. BONE SCAN SHOWED THAT THE FEMORAL COMPONENT COULD BE LOOSE. IT IS UNKNOWN WHEN THE IMPLANT BECAME LOOSE. THE FEMORAL COMPONENT WAS REMOVED WITH NO BONE LOSS. THE CEMENT WAS COMPLETELY DE-BONDED FROM THE IMPLANT INTERFACE. THE SURGEON WAS ABLE TO RE-IMPLANT WITH A SIZE 2 PS PRIMARY FEMUR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 12569714 ↗
• InjuryOct 29, 2019Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD TKA DONE ON (B)(6) 2018 ON RIGHT KNEE. PATIENT HAD REVISION SURGERY ON (B)(6) 2019 SCHEDULED FOR A POLY SWAP DUE TO SUSPICION OF INFECTION. DURING THE PROCEDURE, THE FUMUR WAS DETERMINED TO BE LOOSE. SURGEONS REMOVED ALL COMPONENTS AND ATTEMPTED TO IMPLANT A KNEE INTERSPACE. SURGEONS DETERMINED THE KNEE WOULD NOT ACCOMMODATE THE THICKNESS OF THE INTERSPACE AND CALLED STRYKER TO BRING IN A FEMORAL COMPONENT AND CEMENTED TIBIAL POLY TO STAGE THE PATIENT FOR A REVISION SURGERY.

  Patient problems: Ambulation or Postural Difficulties; Bacterial Infection; Balance Problems; Discomfort; No Code Available; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 9250423 ↗