MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 2.5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	TRULIANT TIB IMP PS INSERT SZ 2.5 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6).02-012-60-1425 - tru stem ext 14mm x 25mm.(b)(6).02-020-11-0225 - truliant ps cem fem ps cem left sz 2.5.(b)(6).02-022-45-2525 - truliant tib fit tray cem sz 2.5f / 2.5t.(b)(6).200-02-32 - three peg patella 32mm.(b)(6).204-70-00 - tibial stem ext.Screw.Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6)2017.Approximately 5 years and 3 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 device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2023.Diagnosis: failed left knee due to premature poly wear of the tibial polyethylene and loose femoral component findings: there was found to be a clean wound with clear synovial joint fluid.There was a moderate amount of polyethylene wear, which was visible with pitting of the tibial polyethylene.There was evidence of encapsulated polyethylene debris with a thickened synovium.A complete synovectomy was performed.There was found to be a loose femoral component from the cement mantle.There was mild osteolysis of the femur behind the cement mantle.
Additional Manufacturer Narrative
1038671-2024-04993 multiple mdr reports were filed for this event, please see associated report: 1038671-2024-04993.This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6 (type of investigation, investigation findings, investigation conclusions).The following sections were corrected: h6 (health effect - clinical code, component code).The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and 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 TIB IMP PS INSERT SZ 2.5 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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: geoff gannon ; 3523771140
• MDR Report Key: 17550050
• Report Number: 1038671-2023-01953
• Device Sequence Number: 6657664
• Product Code: JWH
• UDI-Device Identifier: 10885862304162
• UDI-Public: 10885862304162
• 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: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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 Expiration Date: 03/30/2025
• Device Model Number: TRULIANT TIB IMP PS INSERT SZ 2.5 9MM
• Device Catalogue Number: 02-022-35-2509
• 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: 07/14/2023
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2017
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Unknown