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

Model Number	TRULIANT TIB IMP PS INSERT SZ 2 9MM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Lack of Effect (4065)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Arthrofibrosis (4885)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device return anticipated as they remain implanted.Concomitant medical products: 02-020-11-0220 - truliant ps cem fem ps cem left sz 2 sn: (b)(4), 02-022-45-2020 - truliant tib fit tray cem sz 2f / 2t sn: (b)(4), 200-07-32 - advanced patella 32mm 3 peg implant sn: (b)(4), 201-78-82 - collar fixation pin 2pk 40mm, quick release sn: (b)(4), 201-78-89 - 3" drill bit, mod.Hex 2 pack sn: (b)(4), sn: (b)(4), 521-78-31 - threaded pin size 2.6 collarless 2pk sn: (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via a clinical study, truliant knee clinical study, that a female 53 yo caucasian patient, height: 69 in, weight: 210 lbs, who was initially implanted on (b)(6) 2022, for the primary diagnosis of osteoarthritis, presented to the clinic with arthrofibrosis - stiffness and inadequate rom, date of event onset, (b)(6) 2022.Manipulation under anesthesia to be scheduled.The study indicates the event is definitely not related to device, and definitely related to procedure.Outcome is continuing.
Additional Manufacturer Narrative
H6: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the manipulation under anesthesia cannot be conclusively determined; however, it is most likely related to patient conditions.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b2, b3 (remove erroneous date from initial report) d1, d4 (remove all from initial report-suspect device unknown), g4 (remove 501k from initial report-unknown), h4 (remove erroneous date from initial report), h6 clinical code, health impact code, device problem code, component code, type of investigation, investigation findings, investigation conclusion codes.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: TRULIANT KNEE COMPONENTS
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• 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 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15568196
• Report Number: 1038671-2022-01146
• Device Sequence Number: 12252027
• Product Code: JWH
• UDI-Device Identifier: 10885862304063
• UDI-Public: 10885862304063
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2025

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: 06/14/2026
• Device Model Number: TRULIANT TIB IMP PS INSERT SZ 2 9MM
• Device Catalogue Number: 02-022-35-2009
• 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: 08/22/2022
• Supplement Date Received by Manufacturer: 09/22/2022; 10/24/2025
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 10/19/2022; 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2008
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Race: White