MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 02-012-35-3015

Device Problem Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 04/14/2023

Event Type  Injury  

Manufacturer Narrative

D10.Concomitants: 3766413 02-010-01-0330 - logic femoral ps cem right sz 3 2311361 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t 3798348 200-02-32 - three peg patella 32mm 3805094 204-34-02 - fluted stem extension 25l x 14 mm 3703929 204-70-00 - tibial stem ext.Screw.These devices are used for treatments, not diagnosis.There is no other information available.

Event Description

It was reported via legal documentation that a patient had a right total knee arthroplasty on (b)(6) 2015, and then experienced revision surgical procedure on (b)(6) 2023 approximately 8 years and 3 months after initial implant.No images were provided.There is no other information available.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 3 15MM
• Type of Device: 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 court; gainesville FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 19132542
• MDR Text Key: 340455144
• Report Number: 1038671-2024-00909
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862001832
• UDI-Public: 10885862001832
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/18/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2017
• Device Catalogue Number: 02-012-35-3015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 04/18/2024
• Date Device Manufactured: 05/12/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0021-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female