MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC TIB INSERT SIZE 2, 21MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-65-2021
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 4 months after a left knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain, instability, and popping.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10: concomitants: 18818 cs-10cc - intersep calcium sulfate; 4758501 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t; 5408248 02-012-60-1280 - tru stem ext 12mm x 80mm; 5669548 02-012-60-1080 - tru stem ext 10mm x 80mm; 6743839 02-010-06-0220 - tru cc femoral size 2 left; 7090519 200-02-35 - three peg patella 35mm; ab7921 1400-ag - cemex gento low viscosity 40g kit.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and instability.The reported prosthesis wear and instability could not be confirmed and 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 h6: corrected health effect, medical device and investigation clinical codes.

• Brand Name: LOGIC CC TIB INSERT SIZE 2, 21MM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20171514
• Report Number: 1038671-2024-03375
• Device Sequence Number: 12796441
• Product Code: JWH
• UDI-Device Identifier: 10885862265920
• UDI-Public: 10885862265920
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2025
• Device Catalogue Number: 02-012-65-2021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 11/17/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 10/22/2024
• Date Device Manufactured: 04/26/2017
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown