MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3 9MM; SEE H10

Model Number	TRULIANT TIB IMP PS INSERT SZ 3 9MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ankylosis (4527); Unspecified Musculoskeletal problem (4535)
Date of Event	11/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 68 yo female patient, initial left knee implanted on (b)(6) 2018, underwent a revision procedure on (b)(6) 2023, approximately 5 years 1 month post the initial procedure.The patient presented to the surgeon with a stiff knee.The poly and femur were replaced due to the stiffness.The replacement femur component was a competitor¿s device.There were no surgical delays or device breakages during the procedure.The patient had a successful revision case.The revision case turned out well.No device returns available.The rep does not have the device but sent pictures.X-ray images were also provided.No patient information or history was known.No further information.
Additional Manufacturer Narrative
D10: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6, h11.The following sections were corrected: d1, h6.H11: the reported event was unable to be confirmed due to limited information received from the customer.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, it may be due to patient factors/etiology, component positioning, arthrofibrosis, infection and/or implant selection.This cannot be confirmed because the devices were not available for evaluation.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 3 9MM
• Common Device Name: SEE H10
• 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18407195
• Report Number: 1038671-2023-03063
• Device Sequence Number: 8767880
• Product Code: JWH
• UDI-Device Identifier: 10885862304254
• UDI-Public: 10885862304254
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: 2023
• 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): 04/17/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: TRULIANT TIB IMP PS INSERT SZ 3 9MM
• Device Catalogue Number: 02-022-35-3009
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female