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

Model Number	TRULIANT TIB IMP CR INS STD SZ 4, 9MM
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094)
Date of Event	06/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: serial #: (b)(4), category #: 02-020-13-0340 - truliant cr cem fem cr cem right sz 4, serial #: (b)(4), category #: 02-022-45-4040 - truliant tib fit tray cem sz 4f / 4t, serial #: (b)(4), category #: 200-02-38 - three peg patella 38mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
Legal case - (b)(6).Per report via the legal department, the patient had an initial right knee replacement done on (b)(6) 2020.The patient had the right knee revised on (b)(6) 2022 approximately 2 years and 4 months after the initial procedure.Postoperative diagnosis: right knee post op pain.Serial #: (b)(4), category #: 02-022-47-4009 - truliant tib imp cr ins std sz 4, 9mm, serial number (b)(4) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510k: k152170.Concomitants: serial #: (b)(4), category #: 02-020-13-0340 - truliant cr cem fem cr cem right sz 4, serial #: (b)(4), category #: 02-022-45-4040 - truliant tib fit tray cem sz 4f / 4t, serial #: (b)(4), category #: 200-02-38 - three peg patella 38mm.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
There is no additional information available.Correction - f10-should be blank.
Event or Problem Description
Revision operative report of (b)(6) 2022.Indication for surgery, this 61 yo female has a recalled polyethylene liner.The patient was having postoperative pain and had a negative infection work-up.Poly exchange was done replacing the 9mm to a 10mm poly.At the time of surgery there was noted to be some overgrowth of bone along the medial tibial tray as well as an ossified fragment in the posterior medial joint line that was removed.There is some mild wear on the posterior medial corner of the polyethylene and some mild wear along the surface of the polys there was no significant osteolysis seen and minimal synovitis.Sterile dressings were applied, and the patient was taken to recovery room in stable condition, there were no surgical complication.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.
Additional Manufacturer Narrative
H6: investigation results: the revision reported may have been the result of polyethylene wear as stated in the operative notes.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, the extent and root cause of the reported polyethylene wear cannot be confirmed as the devices were not available for evaluation and radiographs/ photographs were not provided.

• Brand Name: TRULIANT TIB IMP CR INS STD SZ 4, 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16731135
• Report Number: 1038671-2023-00668
• Device Sequence Number: 20482268
• Product Code: JWH
• 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: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/02/2026

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: 07/05/2026
• Device Model Number: TRULIANT TIB IMP CR INS STD SZ 4, 9MM
• Device Catalogue Number: 02-022-47-4009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 07/19/2023; 09/22/2023; 05/12/2026
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 07/19/2023; 10/04/2023; 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2018
• 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: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0023-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female