MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC TIB INSERT SIZE 3, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-65-3013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Fall (1848); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: 6407565 02-010-66-2002 - metaphyseal femoral cone, medium, h42mm.6524455 02-012-64-1812 - tru fluted stm ext 18mm x120mm blast.7176847 02-012-66-2000 - metaphyseal tibial cone, ml32mm.A264225 02-010-06-0230 - tru cc femoral size 3 left.A318649 02-012-50-3014 - tru tib aug 1/2 rl sz 3, 10mm.A633085 200-02-38 - three peg patella 38mm.A693416 02-022-45-3030 - truliant tib fit tray cem sz 3f / 3t.A872427 02-012-64-1880 - tru fluted stm ext 18mm x 80mm blast.A873212 02-010-06-0531 - tru post.Aug.Size 3, 5mm.A878523 208-05-03 - cc distal fem augment sz 3, 5mm.A878528 208-05-03 - cc distal fem augment sz 3, 5mm.
Event or Problem Description
As reported, the patient had a previous revision on (b)(6) 2024; reason not reported.The patient fell and split open wound and underwent an incision and drainage with poly swap on (b)(6) 2024.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.
Event or Problem Description
As reported, the patient had a previous revision; reason not reported.The patient fell and split open wound and underwent an incision and drainage with poly swap.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
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, g3, h6.Mdr section codes updated/corrected: b, c, d, e.The reason for the reopened surgical wound reported cannot be conclusively determined but may be due to the reported fall.The event cannot be confirmed because the devices were not available for evaluation, and relevant patient information, images, or radiographs were not provided.An additional contributing factor to the revision may have been inclusion of the polyethylene in the packaging recall.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: LOGIC CC TIB INSERT SIZE 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: 19973386
• Report Number: 1038671-2024-02812
• Device Sequence Number: 12531524
• Product Code: JWH
• UDI-Device Identifier: 10885862613400
• UDI-Public: 10885862613400
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 10/22/2025

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 Catalogue Number: 02-012-65-3013
• 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: 02/27/2024
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 133 KG