MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-51-3009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11.D10.Concomitants - product information: 5683703 - 200-02-35 - three peg patella 35mm pending investigation.There is no other information available.
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 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
H6: corrected the following: health effect - clinical code, component code, type of investigation, investigation findings, investigation conclusions manufacturer narrative updated: the reason for the reported event cannot be confirmed from the information provided but may have been due to prosthesis wear.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 3, 9MM
• 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: 19625514
• Report Number: 1038671-2024-02172
• Device Sequence Number: 20884231
• Product Code: JWH
• UDI-Device Identifier: 10885862307637
• UDI-Public: 10885862307637
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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: 02-022-51-3009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2018
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown