MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-020-11-0345
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Swelling/ Edema (4577)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 02-022-35-4509 - truliant tib imp ps insert sz 4.5 9mm (b)(4), 02-022-45-4545 - truliant tib fit tray cem sz 4.5f/4.5t (b)(4), and 200-07-32 - advanced patella 32mm 3 peg implant (b)(4).Recall: z-0023-2022.
Event or Problem Description
As reported, the patient had an initial right tka on (b)(6) 2020.The patient complained of pain and was revised on (b)(6) 2023 due to a loose femur.The doctor used competitor's implants for the revision due to the recall.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of an insufficient bond between the femoral component and the bone and/or patient-related conditions, which led to aseptic (non-infected) femoral loosening and pain.However, this cannot be confirmed as the devices were not available for evaluation.
Additional Manufacturer Narrative
The revision reported was likely the result of an insufficient bond between the femoral component and the bone and/or patient-related conditions, which led to aseptic (non-infected) femoral loosening and pain.However, this cannot be confirmed as the devices were not available for evaluation.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 revision reported was likely the result of an insufficient bond between the femoral component and the bone and/or patient-related conditions, which led to aseptic (non-infected) femoral loosening and pain.However, this cannot be confirmed as the devices were not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It is reported via legal documentation approximately 34 months after a right total knee arthroplasty the patient underwent a revision surgery to address prosthesis wear, pain and swelling.A revision operative report was provided.Post operative diagnosis noted failed right total knee arthroplasty secondary to early polyethylene wear from a recalled polyethylene insert.It was noted that radiographs showed stable implants and on exam, the patient had good stability.Intra-operative findings noted synovitis with evidence of polyethylene debris, scar tissue around the patellar button.The surgeon noted that on gross inspection of the insert, there was no obvious wear, the femoral component was de-bonded from cement mantle.No surgical or medical interventions were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of the pain.Additional reasons for the reported revision may be femoral loosening and inclusion of the polyethylene in the packaging recall.Both the alleged femoral loosening and prosthesis wear could not be confirmed from the provided radiographs.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 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 PS CEM FEM PS CEM RIGHT SZ 4.5
• 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: 16748264
• Report Number: 1038671-2023-00699
• Device Sequence Number: 3428906
• Product Code: JWH
• UDI-Device Identifier: 10885862314574
• UDI-Public: 10885862314574
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/30/2025

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 Model Number: 02-020-11-0345
• Device Catalogue Number: 02-020-11-0345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/27/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 06/13/2023; Not provided; 02/27/2025; 07/29/2025
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 06/27/2023; 02/26/2025; 03/10/2025; 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2017
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male