MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 2.5, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC TIB INSERT IMPL CRC, SZ 2.5, 13MM
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377)
Date of Event	03/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per a report from the legal department a female patient (dob (b)(6) 1951) had a left knee replacement on (b)(6) 2017.Approximately 5 years and 7 months after the initial procedure the patient had a left knee revision on (b)(6) 2022.Op report: the surgeon reported that there was excessive synovitis characteristic of third body wear from polyethylene debris.The tibia had extensive osteolysis and loosening.The patient was awakened and transferred to the recovery room in good condition.There were no complications during the procedure.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
D10: concomitants: serial #: (b)(4), category #: 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 2.5t, serial #: (b)(4), category #: 02-010-03-0225 - logic cr femoral cem, left sz 2.5, serial #: (b)(4), category #: 200-02-35 - three peg patella 35mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 2.5, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16784226
• Report Number: 1038671-2023-00787
• Device Sequence Number: 5683481
• Product Code: JWH
• UDI-Device Identifier: 10885862230386
• UDI-Public: 10885862230386
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• 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): 01/15/2025

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: 04/15/2021
• Device Model Number: LOGIC TIB INSERT IMPL CRC, SZ 2.5, 13MM
• Device Catalogue Number: 02-012-51-2513
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female