MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-4009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant devices: (b)(6), 02-020-11-0240 - truliant ps cem fem ps cem left sz 4; (b)(6), 02-022-45-4040 - truliant tib fit tray cem sz 4f / 4t; (b)(6), 200-07-32 - advanced patella 32mm 3 peg implant.H3: the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that this patient's left knee was revised approximately 6 years and 2 months post initial procedure.Patient complained of pain and had a recalled poly.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The revision reported was likely the result of patellar prosthesis wear, or due to the inclusion of the tibial insert in the packaging recall.Possible causes for polyethylene wear include third body wear or patient-related conditions.As the suspect device was not provided, these potential causes or their contribution to the sequence of events cannot be confirmed.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 4 9MM
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21218039
• Report Number: 1038671-2025-00363
• Device Sequence Number: 8786162
• Product Code: JWH
• UDI-Device Identifier: 10885862304438
• UDI-Public: 10885862304438
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• 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
• Report Date (Section B): 07/23/2025

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: 08/21/2026
• Device Catalogue Number: 02-022-35-4009
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 07/23/2025
• Date Device Manufactured: 08/21/2018
• 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: 65 YR
• Patient Sex: Male