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

Catalog Number	02-022-51-3009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10.Concomitants: (b)(6) 02-010-03-0230 - logic cr femoral cem, left, sz 3; (b)(6) 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t; (b)(6) 204-70-00 - tibial stem ext.Screw; (b)(6) 200-02-38 - three peg patella 38mm; (b)(6) 02-012-60-1440 - tru stem ext 14mm x 40mm.These devices are used for treatment not diagnosis.There is no additional information available.Pending investigation.
Event or Problem Description
It is reported via legal documentation that patient had a left knee revision on (b)(6) 2023 and per the information provided, the devices remain implanted.No other information was provided.
Additional Manufacturer Narrative
H6: corrected the following: type of investigation, investigation findings, investigation conclusions.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 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.Additionally, this device was packaged after initiation of the recall and was not packaged in a non-conforming vacuum bag.

• Brand Name: TRULIANT
• 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 ; 3523771140
• MDR Report Key: 19631716
• Report Number: 1038671-2024-02207
• Device Sequence Number: 21031053
• 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: 2023
• 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): 11/08/2024

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: 06/18/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• 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