MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	TRULIANT TIB IMP PS INSERT SZ 3 11MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Synovitis (2094); Implant Pain (4561)
Date of Event	10/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient, had an initial right knee implanted on (b)(6) 2018, and underwent a revision procedure on (b)(6) 2022, approximately 3 years 11 months post the initial implant procedure for medial knee pain.It was noted there was some synovitis and scar tissue medial.A thicker insert was selected after trialing.The original ps insert was 11mm.A 13mm was implanted with good stability and range of motion.It was stated that the poly had no visual damage upon removal.The explants not available to the sales rep.The patient left in stable condition.No patient information/medical history reported.
Additional Manufacturer Narrative
Concomitant medical products: 3756889, 208-05-03, cc distal fem augment sz 3, 5mm 3900323, 208-05-03, cc distal fem augment sz 3, 5mm 4867320, 02-012-61-6000, logic offset stem ext coupler 6mm 5045456, 02-010-06-0531, logic post.Aug.Block size 3, 5mm 5126743, 02-010-06-0330, logic cc femoral size 3, right 5179770, 02-012-45-3020, lgc tibial fit tray cem sz 3f / 2t 5218705, 02-012-61-2000, logic offset stem ext coupler 2mm 5233057, 204-70-00, tibial stem ext.Screw 5245990, 02-012-60-1425, logic stem ext 14mm x 25mm 5245997, 02-012-60-1425, logic stem ext 14mm x 25mm 5282342, 02-010-06-0531, logic post.Aug.Block size 3, 5mm.H6: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the pain and subsequent revision cannot be conclusively determined; however, it is most likely patient-related conditions.
Event or Problem Description
It was reported that a female patient, had an initial right knee implanted and underwent a revision procedure, approximately 3 years 11 months post the initial implant procedure for medial knee pain.It was noted there was some synovitis and scar tissue medial.A thicker insert was selected after trailing.The original ps insert was 11mm.A 13mm was implanted with good stability and range of motion.It was stated that the poly had no visual damage upon removal.The explants not available to the sales rep.The patient left in stable condition.No patient information/medical history reported.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d1, h6 clinical 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 TIB IMP PS INSERT SZ 3 11MM
• 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 ; 3523771140
• MDR Report Key: 15756270
• Report Number: 1038671-2022-01427
• Device Sequence Number: 4897482
• Product Code: JWH
• UDI-Device Identifier: 10885862304278
• UDI-Public: 10885862304278
• 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
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: 10/18/2025
• Device Model Number: TRULIANT TIB IMP PS INSERT SZ 3 11MM
• Device Catalogue Number: 02-022-35-3011
• 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: 10/12/2022
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 02/19/2026
• Date Device Manufactured: 10/18/2017
• 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
• 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; Hospitalization
• Patient Sex: Female