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

Catalog Number	02-022-35-2011
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	04/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 02-020-11-0320 - truliant ps cem fem ps cem right sz 2: 5232250; 02-022-45-2020 - truliant tib fit tray cem sz 2f / 2t: 5099979; 200-07-35 - advanced patella 35mm 3 peg implant: 5258072; 201-78-82 - collar fixation pin 2pk 40mm, quick release: 5249209; 201-78-89 - 3" drill bit, mod.Hex 2 pack: 5221157; 201-78-89 - 3" drill bit, mod.Hex 2 pack: 5221161; 201-78-89 - 3" drill bit, mod.Hex 2 pack: 5221164.
Event or Problem Description
As reported by the exactech truliant knee clinical study, the 70 year old male patient had an initial right tka on (b)(6) 2018 and presented with ligament laxity 2 year(s) and 2 month(s) post initial procedure on (b)(6) 2022.The patient complained of pain and instability.Rx'd hinged knee brace for ligament laxity causing slight bilateral opening.The case report form indicates that this event is definitely not related to the device and definitely related to the procedure.The report also indicates that the action of prescribing a hinged knee brace was taken and the outcome was resolved on (b)(6) 2022.Due to clinical study, no devices will be returned for evaluation.
Additional Manufacturer Narrative
B3: occurred in 2022 - specific date unknown.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 resulted from soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.Instability is a known risk, as outlined in the ifu.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 COMPONENTS
• 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 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville 32653 ; 3523771140
• MDR Report Key: 18637116
• Report Number: 1038671-2024-00150
• Device Sequence Number: 20815823
• Product Code: JWH
• UDI-Device Identifier: 10885862304087
• UDI-Public: 10885862304087
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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: 09/07/2025
• Device Catalogue Number: 02-022-35-2011
• 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: 01/10/2024
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 02/03/2024
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2017
• 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
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Race: White