MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 9MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 03/29/2024

Event Type  Injury  

Event Description

As reported, approximately three years post initial left tka, the male patient was suffering from laxity and pain.Patient had a revision surgery an early granuloma on pe synovectomy was performed, liner pe changed.There was no breakage of device or surgical delay/prolongation.Sales rep was unable to obtain photos/x-rays.The device is not available for evaluation.

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 9MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 19160079
• MDR Text Key: 340795178
• Report Number: 1038671-2024-00935
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862173591
• UDI-Public: 10885862173591
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K110547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/22/2024

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: 12/03/2023
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 9MM
• Device Catalogue Number: 02-012-44-3509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/04/2015
• 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 Sex: Male