MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-5011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 02-022-35-4513 - truliant tib imp ps insert sz 4.5 13mm.(b)(6), 02-012-60-1425 - tru stem ext 14mm x 25mm.(b)(6), 02-020-11-0245 - truliant ps cem fem ps cem left sz 4.5.(b)(6), 02-022-45-4545 - truliant tib fit tray cem sz 4.5f/4.5t.(b)(6), 200-07-35 - advanced patella 35mm 3 peg implant.(b)(6), 201-78-18 - holding pin headless no ribs w/30 deg pt 4 pack.(b)(6), 204-70-00 - tibial stem ext.Screw.
Event or Problem Description
It was reported that a male patient, initial right knee implanted in (b)(6) 2018, underwent a revision procedure in (b)(6) 2024, approximately 5 years 11 months post the initial procedure.The patient presented with complaints of pain.They were revised to a competitor¿s devices due to the recall.Recalled poly indicated.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.The explanted devices are not available due the recall, the hospital will not release them.An image of the explanted devices was provided.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: a2 - dob and age in years at time of event d4 - catalog, exp date, serial, udi d6a - implant date h4 - mfg date h6 - component, inv type, findings, conclusion codes d10: concomitants: (b)(6) 02-020-11-0350 - truliant ps cem fem ps cem right sz 5.(b)(6) 02-022-45-5050 - truliant tib fit tray cem sz 5f / 5t.(b)(6) 200-07-35 - advanced patella 35mm 3 peg implant.(b)(6) 204-70-00 - tibial stem ext.Screw.(b)(6) 02-012-60-1425 - tru stem ext 14mm x 25mm.The following sections were corrected: b5 - right knee initially implanted in (b)(6) 2018, revision occurred approximately 6 years 3 months post.D6a - date correction.D10 - prior reported concomittants no longer applies.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported was likely due to the reported pain, or due to the inclusion of the polyethylene in the packaging recall.Wear of the insert could not be confirmed from the provided images.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 5 11MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 19956187
• Report Number: 1038671-2024-02766
• Device Sequence Number: 8801775
• Product Code: JWH
• UDI-Device Identifier: 10885862304636
• UDI-Public: 10885862304636
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2025

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: 05/24/2025
• Device Catalogue Number: 02-022-35-5011
• 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: 08/01/2024
• Supplement Date Received by Manufacturer: 04/30/2025; 06/05/2025
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 04/30/2025; 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2017
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 149 KG