MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-44-3013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 7 years and 1 month post the initial left total knee arthroplasty, the patient complained of pain and was revised to competitor devices.The patient has a recalled insert and patella.This is the fourth surgery for this patient.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.Concomitants: 200-02-38 three peg patella 38mm 02-022-45-9999 - fit tray revision add unassigned 02-012-44-3013 - logic tibia implant psc insert, sz 3, 13mm (b)(6) 02-012-61-2000 - tru offset stem ext coupler, 2mm (b)(6) 208-06-03 - cc distal fem augment sz 3, 10mm (b)(6) 02-010-66-2002 - metaphyseal femoral cone, medium, h42mm (b)(6) 02-012-60-1480 - tru stem ext 14mm x 80mm (b)(6) 02-012-60-1680 - tru stem ext 16mm x 80mm (b)(6) 02-012-45-3020 - lgc tibial fit tray cem sz 3f / 2t (b)(6) 02-010-06-0532 - tru post.Aug.Size 3, 10mm (b)(6) 02-010-06-0230 - tru cc femoral size 3 left (b)(6) 02-012-61-4000 - tru offset stem ext coupler, 4mm (b)(6) 204-70-00 - tibial stem ext.Screw (b)(6).201-78-81 - 3" trocar, mod.Hex 2pk (b)(6).201-78-81 - 3" trocar, mod.Hex 2pk (b)(6).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d.The reason for the revision reported was due to the reported pain which was the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall and being packaged in a non-conforming vacuum bag for more than five years.Prosthesis wear of the patella could not be confirmed as images of the explanted device were not provided.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 IMPLANT PSC INSERT, SZ 3, 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20419269
• Report Number: 1038671-2024-03920
• Device Sequence Number: 18240116
• Product Code: JWH
• UDI-Device Identifier: 10885862173577
• UDI-Public: 10885862173577
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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: 04/01/2022
• Device Catalogue Number: 02-012-44-3013
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 07/03/2025
• Date Device Manufactured: 04/01/2014
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Unknown