MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB FIT TRAY CEM SZ 4F / 3T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-45-4030
Medical Device Problem Codes	Fracture (1260); Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 69 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, progressive left knee leg complaints.Revision surgery operative notes were provided.Patient left the operating room in stable condition.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10 concomitant devices ((b)(6)) 201-78-15 - holding pin mini sharp point 4 pk ((b)(6)) 200-02-35 - three peg patella 35mm ((b)(6)) 201-78-80 - 3"" trocar, hex 2pk ((b)(6)) 02-010-01-0240 - logic femoral ps cem left sz 4 ((b)(6)) 02-022-45-4030 - truliant tib fit tray cem sz 4f / 3t the product associated with the reported event is within the scope of recall however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of tibial loosening and prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.D10: (b)(6) - 02-010-01-0240 - logic femoral ps cem left sz 4.(b)(6) - 02-022-35-4017 - truliant tib imp ps insert sz 4 17mm.(b)(6) - 02-012-61-4000 - tru offset stem ext coupler, 4mm.(b)(6) - 02-012-60-1280 - tru stem ext 12mm x 80mm.(b)(6) - 204-70-00 - tibial stem ext.Screw.(b)(6) - 200-02-35 - three peg patella 35mm.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-03743.
Event or Problem Description
It was reported that approximately 69 months after a left total knee replacement procedure, the patient underwent a second revision procedure to address recurrent tibial loosening and progressive left knee and leg complaints.Revision surgery operative notes were provided.Pre/post operative diagnoses: failed left total knee arthroplasty with recurrent tibial baseplate loosening and impending epiphyseal tibial fracture and stem tip.On exam under anesthesia, the knee exhibited mild laxity to varus and valgus stress in full extension, mid and deep flexion, and had a mild varus alignment noted on visual inspection.Operative findings indicated the synovial lining was mildly inflamed, hypertrophied, and contained numerous bead like projections consistent with particle disease.The poly insert exhibited minimal evidence of poly wear.The femoral component was found to be well fixed to bone with anderson type i distal femoral bone loss.The tibial base plate was loose.The tibia exhibited anderson ii-a medial and central bone loss.The patellar button exhibited significant wear, thinning, and delamination.The surgeon performed a revision left total knee arthroplasty using a competitor¿s devices.Complications: while reaming the tibial canal in preparation for the tibial cone, a small crack developed in the posterior cortex of the proximal tibia.This was an incomplete fracture, and a 3.5 mm screw was placed from medial to lateral across the posterior cortex of the proximal tibia, which successfully compressed the fracture and supported the medial side.The patient was subsequently awoken and transferred to the pacu in stable condition.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of instability, tibial loosening, and prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT TIB FIT TRAY CEM SZ 4F / 3T
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 20334339
• Report Number: 1038671-2024-03744
• Device Sequence Number: 8003741
• Product Code: JWH
• UDI-Device Identifier: 10885862305879
• UDI-Public: 10885862305879
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02-022-45-4030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 05/08/2025; 05/08/2025; 05/21/2025
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 05/08/2025; 05/08/2025; 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male