MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	02-012-35-5011
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Implant Pain (4561); Insufficient Information (4580); Joint effusion (4849)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, a patient had bilateral knee replacement on (b)(6)2014.The patient plans to have left knee revision surgery in (b)(6) of 2023, the reason for which has not been reported.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: 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), 02-012-35-5011 - logic tibia ps mod insrt sz 5 11mm (b)(6), 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t (b)(6), 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t (b)(6), 200-02-41 - three peg patella 41mm (b)(6), 200-02-41 - three peg patella 41mm (b)(6).
Additional Manufacturer Narrative
H10.Additional information- a2, a3, b1, b3, b5, d5, d6b, h6.These devices are used for treatment not diagnosis.There is no additional information available.Pending investigation.H11.Correction ¿ d4 serial number, d4 expiration date.
Event or Problem Description
It was reported that the patient complained of pain; he had a loose femur and recalled poly.Left side revision of exactech implants.Reported revision is not related to breakage of device and did not lead to surgical delay/prolongation.Patient was last known to be in stable condition following the event.No further information provided.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-03220, 1038671-2024-03220.This follow-up report is being submitted to relay additional and/or corrected information.The revision reported in (b)(4) was likely the result of prosthesis wear.Additional reasons for the reported revision may be femoral loosening and inclusion of the polyethylene in the packaging recall.However, the reported femoral loosening could not be confirmed from the provided information.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 5 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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 ; 3523782617
• MDR Report Key: 17602526
• Report Number: 1038671-2023-02022
• Device Sequence Number: 6125588
• Product Code: JWH
• UDI-Device Identifier: 10885862001931
• UDI-Public: 10885862001931
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/24/2018
• Device Catalogue Number: 02-012-35-5011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 11/15/2023; 02/25/2025
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 05/23/2024; 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male