MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Swelling/ Edema (4577)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 4.1 years post initial right side tka, the 59 y/o male patient had a revision due to extensive synovitis was noted, and oxidative wear both on the medial and lateral aspect of the polyethylene.Patient had a poly exchange.There was no breakage of the device or surgical delay prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos/x-rays.The device is not available for evaluation.No other patient information/medical history reported.
Additional Manufacturer Narrative
After further review of additional information received the following sections d1, d4, g3, g6, h2, h4, h6 and h9 have been updated accordingly.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of prosthesis wear.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear could not be determined as the device was not returned for evaluation, and images and radiographs were not provided h6: corrected: health effect - clinical code, component code, type of investigation, investigation findings, and investigation conclusions.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16448850
• Report Number: 1038671-2023-00259
• Device Sequence Number: 17603233
• Product Code: JWH
• UDI-Device Identifier: 10885862174529
• UDI-Public: 10885862174529
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2024

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: 02/06/2025
• Device Model Number: LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM
• Device Catalogue Number: 02-012-49-4011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 08/21/2023; 04/04/2024
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 09/11/2023; 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2017
• 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-0021-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male