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

Catalog Number	02-022-35-3511
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	10/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that the patient was implanted with a truliant device on the right knee, with no revision surgery reported.It is stated the patient has suffered the following injuries and complications: pain, stiffness, discomfort, and weakness which in turn negatively affected plaintiff's mobility and quality of life.There was no other patient/medical information provided.No x-rays or images were provided.There is no other information available.
Additional Manufacturer Narrative
H11.Pending investigation.There is no other information provided.
Additional Manufacturer Narrative
D10: (b)(6), 201-78-80 - 3" trocar, hex 2pk; (b)(6), 02-020-11-0335 - truliant ps cem fem ps cem right sz 3.5; (b)(6), 02-022-45-3525 - truliant tib fit tray cem sz 3.5f / 2.5t; (b)(6), 200-07-29 - advanced patella 29m 3 peg implant; (b)(6), 201-78-80 - 3" trocar, hex 2pk; (b)(6), 201-78-15 - holding pin mini sharp point 4 pk; (b)(6), 201-78-80 - 3" trocar, hex 2pk.Manufacturer narrative updated: the reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear and/or inclusion of the polyethylene in the packaging recall.Potential contributions of user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.

• Brand Name: TRULIANT TIBIAL INSERT
• 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 INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 19570905
• Report Number: 1038671-2024-02020
• Device Sequence Number: 20361671
• Product Code: JWH
• UDI-Device Identifier: 10885862304360
• UDI-Public: 10885862304360
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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 Catalogue Number: 02-022-35-3511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown