MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC FEMORAL COMPONENT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 9999

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Osteolysis (2377)

Event Date 05/11/2022

Event Type  Injury  

Event Description

It was reported via legal documentation that a patient had a left total knee arthroplasty on (b)(6) 2015 and then experienced revision surgical procedure on (b)(6) 2022 approximately 6 years and 11 months after initial implant.Op report ; postoperative diagnosis - instability of left knee associated with osteolysis , femoral component was grossly loose.No images were provided.There is no device information provided.There is no other information available.

Manufacturer Narrative

Concomitants: (b)(6) 02-012-35-3511 - logic tibia ps mod insert.This device is used for treatments, not diagnosis.There is no other information available.Pending investigation.

• Brand Name: OPTETRAK LOGIC FEMORAL COMPONENT
• 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: 19103363
• MDR Text Key: 340108013
• Report Number: 1038671-2024-00828
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2024

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 Catalogue Number: 9999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 04/15/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention