MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 2, 13MM; SEE H10

Model Number	02-022-44-2013
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.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 proposed revision or revision cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
Event or Problem Description
It was reported via legal brief that on (b)(6) 2020, a patient underwent a left knee revision surgery in which she was implanted with exactech, left knee revision, serial #(b)(4).It is stated that ¿the left knee revision implant again failed¿; she required an additional revision surgery and will be required to undergo further revision surgery.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.

• Brand Name: TRULIANT TIB IMP PSC INSERT SZ 2, 13MM
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16657264
• Report Number: 1038671-2023-00561
• Device Sequence Number: 1609615
• Product Code: JWH
• UDI-Device Identifier: 10885862304933
• UDI-Public: 10885862304933
• 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: 2020
• 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
• Report Date (Section B): 03/31/2023

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: 08/28/2025
• Device Model Number: 02-022-44-2013
• Device Catalogue Number: 02-022-44-2013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 03/31/2023
• Date Device Manufactured: 08/28/2017
• 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: UNK.
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Female