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

Catalog Number	02-022-48-4009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 02-020-13-0240 - truliant cr cem fem cr cem left sz 4: (b)(6), 02-022-45-4030 - truliant tib fit tray cem sz 4f / 3t: (b)(6), 200-07-29 - advanced patella 29m 3 peg implant: (b)(6), 201-78-15 - holding pin mini sharp point 4 pk: (b)(6), 521-78-23 - threaded pin size 2.3 collared 2pk: (b)(6), 521-78-32 - threaded pin size 3.0 collarless 2pk: (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a patient who had an initial left knee implanted underwent a revision procedure approximately 3 years 6 months post the initial procedure.The patient was revised due to anterior knee pain.Patella osteophytes removed and poly exchange was done with no issues.No device breakages or surgical delay indicated.The patient was last known to be in stable condition following the event.X-rays provided.The explanted devices are not available for return.Device images were provided.No further information.
Additional Manufacturer Narrative
The reason for the clinical symptom of pain reported cannot be conclusively determined and the event cannot be confirmed because the devices were not available for evaluation images were provided and based on those, the revised tibial insert and the radiographs appear unremarkable.D1: corrected g4: corrected h6: corrected health effect and investigation clinical codes.

• Brand Name: TRULIANT TIB IMP CR INS SLOPE+ 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 22007003
• Report Number: 1038671-2025-02040
• Device Sequence Number: 7893024
• Product Code: JWH
• UDI-Device Identifier: 10885862306883
• UDI-Public: 10885862306883
• 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
• Device Explanted Year: 2025
• 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): 07/28/2025

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: 04/01/2023
• Device Catalogue Number: 02-022-48-4009
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown