MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 1.5, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-1513
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case ¿ usa (master case no.(b)(4).It was reported that approximately 8 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain, lateral joint pain, synovitis, swelling, instability, osteolysis.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.The serial number (b)(6) is confirmed to be a part of recall number: z-0023-2022.
Additional Manufacturer Narrative
Concomitants: (b)(6) 02-020-11-0345 - truliant ps cem fem ps cem right sz 4.5 (b)(6) 02-022-45-4535 - truliant tib fit tray cem sz 4.5f/3.5t (b)(6) 02-012-60-1425 - tru stem ext 14mm x 25mm (b)(6) 200-02-35 - three peg patella 35mm (b)(6) 204-70-00 - tibial stem ext.Screw.The product associated with the reported event is within the scope of recall z-0023-2022.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
Corrected concomitant implants, udi#, 510k #.Correct concomitants: 6559109 02-020-11-0315 - truliant ps cem fem ps cem right sz 1.5.6845105 02-022-45-1510 - truliant tray, cem sz 1.5f/1t.7057270 200-07-29 - advanced patella 29m 3 peg implant.6851997 201-78-82 - collar fixation pin 2pk 40mm, quick release.6908324 201-78-89 - 3"" drill bit, mod.Hex 2 pack.6908332 201-78-89 - 3"" drill bit, mod.Hex 2 pack.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6 (type of investigation) the following sections were corrected: b3 h6 (health effect - clinical code, health effect - impact code) the reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear and/or 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, radiographs and relevant clinical information 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 1.5, 13MM
• 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 ct; FL
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20337620
• Report Number: 1038671-2024-03752
• Device Sequence Number: 8046197
• Product Code: JWH
• UDI-Device Identifier: 10885862304018
• UDI-Public: 10885862304018
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2025

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 Expiration Date: 10/01/2022
• Device Catalogue Number: 02-022-35-1513
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: Not provided; 05/08/2025
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 10/01/2024; 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown