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

Catalog Number	02-012-47-3009
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988)
Health Effect - Clinical Codes	Emotional Changes (1831); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)
Date of Event	10/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case ¿ (b)(4).It was reported via legal documentation that approximately 62 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain, swelling, and decreased range of motion; personal injuries, severe pain and suffering, mental anguish, emotional distress, fear, loss of enjoyment of life, medical expenses, and financial losses; future damages.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
Concomitant devices: (b)(6), 02-012-45-3020 - lgc tibial fit tray cem sz 3f / 2t, (b)(6), 02-010-03-0330 - logic cr femoral cem, right, sz 3, (b)(6), 200-02-29 - three peg patella 29mm".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
H6: corrected the following: medical device problem code, type of investigation.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear.The reported prosthesis wear 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.

• Brand Name: LOGIC CR TIB INSERT STD, 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 ne 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19819978
• Report Number: 1038671-2024-02504
• Device Sequence Number: 15620967
• Product Code: JWH
• UDI-Device Identifier: 10885862174345
• UDI-Public: 10885862174345
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2026
• Device Catalogue Number: 02-012-47-3009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2018
• 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; Hospitalization
• Patient Sex: Unknown