MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 13 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-3513
Medical Device Problem Codes	Fracture (1260); Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	08/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 64 y/o male patient's left knee was revised.The patient had an original exactech left total knee replacement.The patient returned to surgeons office complaining of pain, swelling, and dissatisfaction with their left primary knee.The poly and a recalled implant were in question.The poly implant was broken posteriorly in a couple of pieces that were removed from the wound/joint.The patient underwent a tibial poly implant swap.Patient was last known to be in stable condition following the event.Product not returning: implants are sent to the lab and legal.Not given to the representative.
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): cr femoral component sz 3.5 left.Tibia component cemented 3.5f/3.5t.Patella implant - unknown size,.
Additional Manufacturer Narrative
*the following sections have corrected information: (d1) brand name.(d10) concomitant device(s): ((b)(6)) 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t ((b)(6)) 02-010-03-0235 - logic cr femoral cem, left, sz 3.5 ((b)(6)) 200-02-32 - three peg patella 32mm.
Additional Manufacturer Narrative
D4: corrected.G4: corrected.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 13 MM
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20177426
• Report Number: 1038671-2024-03395
• Device Sequence Number: 15686311
• Product Code: JWH
• UDI-Device Identifier: 10885862159335
• UDI-Public: 10885862159335
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2025

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: 08/11/2019
• Device Catalogue Number: 02-012-49-3513
• 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: 08/23/2024
• Supplement Date Received by Manufacturer: 09/24/2024; 07/16/2025
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 10/14/2024; 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2011
• 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 Sex: Female