MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 5 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC TIBIA PS MOD INSRT SZ 5 15MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	10/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the male patient had a bilateral knee replacement on (b)(6) 2014.Approximately 8 years and 5 months after the initial procedure the patient had a bilateral revision on (b)(6) 2022.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2022.Diagnosis: failed bilateral knee arthroplasty secondary to aseptic femoral loosening and polyethylene wear.Femoral component was loose with cyst found posterior lateral.Patient was awakened and taken to recovery room in stable condition.
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 02-010-01-0250 - logic femoral ps cem left sz 5; (b)(6), 02-010-01-0350 - logic femoral ps cem right sz 5; (b)(6), 02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t; (b)(6), 02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t; (b)(6), 200-02-41 - three peg patella 41mm; (b)(6), 200-02-41 - three peg patella 41mm; (b)(6), 02-012-35-5013 - logic tibia ps mod insrt sz 5 13mm.Serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.Pending investigation.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, femoral loosening and/or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 5 15MM
• 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: geoff gannon ; gainesville 32653 ; 3523771140
• MDR Report Key: 17362695
• Report Number: 1038671-2023-01722
• Device Sequence Number: 6041979
• Product Code: JWH
• UDI-Device Identifier: 10885862001955
• UDI-Public: 10885862001955
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 12/02/2024

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 Expiration Date: 05/26/2018
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 5 15MM
• Device Catalogue Number: 02-012-35-5015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 12/02/2024
• Date Device Manufactured: 07/19/2010
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male