MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number	02-022-44-4011
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Joint effusion (4849)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported, the patient had an initial right tka on (b)(6) 2011.The patient was revised on (b)(6) 2021 due to unknown reasons.No other information reported.
Additional Manufacturer Narrative
H3: 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 subsequent revision cannot be conclusively determined, insufficient information.
Event or Problem Description
Revision operative report of (b)(6) 2021 - "examination under anesthesia demonstrates a jog of valgus laxity.Arthrotomy was carried out.There was a large effusion.Synovial fluid was sent for cell count.There was extensive thickened pseudomembrane in the joint but no evidence of infection.Tissue was sent to microbiology for culture as well as to pathology.Complete synovectomy was carried out.There was some pitting on the central post and medial aspect of the polyethylene liner.The patella component, femoral component, and tibial components are all well fixed.There is no loosening.We exchanged the polyethylene implant liner placing an 11 mm psc insert as compared to the prior 9 mm insert.This improved stability as the knee still came out to full extension.Patella tracking is anatomic." the patient was transferred to the recovery room in satisfactory condition.The patient has filed a short-form complaint in a coordinated action in (b)(6) with master case no.(b)(4).The consolidated long form complaint that applies to cases filed in this coordinated action alleges that patients filing suits in this coordinated action were required ¿to undergo revision surgeries due to severe, pain, swelling, and instability¿ due to ¿wear of the polyethylene components and resulting component loosening and/or other failure failures causing serious complications including tissue damage, osteolysis, permanent bone loss, and other injuries.¿ because the patient has filed a short-form complaint in this coordinated action, the patient appears to allege that the patient was injured as a result of wear of an exactech polyethylene device.
Additional Manufacturer Narrative
H3: investigation results - the revision reported may have been the result of polyethylene wear.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the polyethylene wear cannot be determined as the device was not available for evaluation, and radiographs or photographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: e1, e2, e3, g2, h6.

• Brand Name: TRULIANT TIB IMP PSC INSERT
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: michael crader ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15500626
• Report Number: 1038671-2022-01184
• Device Sequence Number: 16592578
• Product Code: JWH
• UDI-Device Identifier: 10885862305282
• UDI-Public: 10885862305282
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/18/2026

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 Catalogue Number: 02-022-44-4011
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/09/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 09/30/2022; 06/08/2023; 02/23/2024; 04/23/2026
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 10/13/2022; 08/23/2023; 02/29/2024; 05/18/2026
• 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
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male