MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT KNEE SYSTEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Ankylosis (4527)
Date of Event	12/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the exactech truliant knee clinical study, the 55-year-old male patient had an initial right tka on (b)(6) 2019 and presented with other-mua, 1 month(s) and 0 year(s) post-operatively on (b)(6) 2019.Patient wasn't getting desired rom.Patient did physical therapy and still only had 0-77 rom.Ankylosis right knee, closed manipulation under anesthesia right knee.The outcome of this event is considered resolved on 27-dec-2020, and the action taken was other - mua right knee.The case report form indicates that this event is definitely not related to the device and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 02-020-11-0320 - truliant ps cem fem ps cem right sz 2: 5827776 02-022-45-2010 - truliant tib fit tray cem sz 2f / 1t: 5749423 200-07-32 - advanced patella 32mm 3 peg implant: 5881932.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: d10, h6, h11.The following sections were corrected: d1, d3, g4, h4, h6.D10: 02-020-11-0320 - truliant ps cem fem ps cem right sz 2: 5827776.02-022-45-2010 - truliant tib fit tray cem sz 2f / 1t: 5749423.200-07-32 - advanced patella 32mm 3 peg implant: 5881932.02-022-35-2010 - truliant tib imp ps insert sz 2 10mm: 5823566.H11: the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.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, may have been due to loss of range of motion secondary to ankylosis, as stated in the reported information.However, this cannot be confirmed and potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b2, b3, d4 (remove expiration date), g4, h4 (remove manufactured date).If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT KNEE SYSTEM
• 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 ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18785128
• Report Number: 1038671-2024-00323
• Device Sequence Number: 7888204
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2026

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
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/23/2026; 02/13/2026
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 02/12/2026; 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2019
• 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 H10.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 78 KG