MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT CR CEM FEM CR CEM RIGHT SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT CR CEM FEM CR CEM RIGHT SZ 3
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Emotional Changes (1831); Failure of Implant (1924); Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: (b)(4), 200-07-32 - advanced patella 32mm 3 peg implant.(b)(4), 02-022-51-3010 - truliant tib imp crc insert sz 3, 10mm.(b)(4), 02-022-45-3020 - truliant tib fit tray cem sz 3f / 2t.
Event or Problem Description
As reported, the patient had an initial right tka on (b)(6) 2018.The patient complained of pain and was revised due to a loose femur.The patient was last known to be in stable condition following the event.No other medical history/patient information provided.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of aseptic loosening between the femoral component and the bone.However, this cannot be determined as the devices were not available for evaluation and limited clinical information was provided.H7: z-0023-2022.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Mdr section codes updated/corrected: e, g.The revision reported was likely the result of aseptic loosening between the femoral component and the bone.However, this cannot be determined as the devices were not available for evaluation and limited clinical information was provided if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening 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 CR CEM FEM CR CEM RIGHT SZ 3
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15447826
• Report Number: 1038671-2022-01136
• Device Sequence Number: 17325896
• Product Code: JWH
• UDI-Device Identifier: 10885862314673
• UDI-Public: 10885862314673
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/03/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: TRULIANT CR CEM FEM CR CEM RIGHT SZ 3
• Device Catalogue Number: 02-020-13-0330
• 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: 08/30/2022
• Supplement Date Received by Manufacturer: 03/15/2023; 02/20/2025; 03/28/2025
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 03/01/2023; 02/25/2025; 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2017
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female