MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 6, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-44-6013
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Joint effusion (4849)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 3.5 years post op initial right tka, this 72 y/o male patient was revised.Patient presented with a sore knee after a fall from a ladder.After opened the knee, surgeon found poly and osteolysis issue.This seems to be from the patella wear.Liner and patella were exchanged.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Photos & x-rays attached.Product not returning - it was discarded.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): (b)(6), 02-010-01-0360 - lgc femoral ps cem right sz 6.(b)(6), 02-012-45-6060 - lgc tibial fit tray cem sz 6f / 6t.(b)(6), 200-02-41 - three peg patella 41mm.(b)(6), 204-34-02 - fluted stem extension 25l x 14 mm.(b)(6), 204-70-00 - tibial stem ext.Screw.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported in was likely the result of the patient¿s reported fall which led to pain.The reported prosthesis wear may have been the result of the orientation of the components, instability, patient related factors, or any combination of these possibilities.However, this cannot be confirmed because the components were not returned for evaluation.Additionally, the insert was packaged in a non-conforming vacuum bag for over five years.
Additional Manufacturer Narrative
"this follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of the patient¿s reported fall which led to pain.The reported prosthesis wear may have been the result of the orientation of the components, instability, patient related factors, or any combination of these possibilities.However, this cannot be confirmed because the components were not returned for evaluation.Additionally, the insert was packaged in a non-conforming vacuum bag for over five years.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 IMPLANT PSC INSERT, SZ 6, 13MM
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17682323
• Report Number: 1038671-2023-02146
• Device Sequence Number: 17712490
• Product Code: JWH
• UDI-Device Identifier: 10885862173874
• UDI-Public: 10885862173874
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2025

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: 07/09/2022
• Device Catalogue Number: 02-012-44-6013
• 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: 08/15/2023
• Supplement Date Received by Manufacturer: 12/04/2023; 03/13/2025
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 12/19/2023; 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2014
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 100 KG