MAUDE Adverse Event Report: EXACTECH, INC. INSERT TIBIA LOGIC PS SZ3 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number UNKNOWN

Device Problem Degraded (1153)

Patient Problem Debris, Bone Shedding (1803)

Event Date 06/19/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2009, a (b)(6) y/o, female patient with a bmi of 25.1 underwent implantation of a insert tibia logic ps sz3 9mm, serial # (b)(4).On (b)(6) 2018, approximately 104 months post implant, the patient underwent revision due to debris synovistis.

Manufacturer Narrative

(h2) this report is a duplicate of mfr# 1038671-2018-00495, 1038671-2018-00496, 1038671-2018-00497 and 1038671-2018-00498.Any subsequent information would be reported under those reports.

• Brand Name: INSERT TIBIA LOGIC PS SZ3 9MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10370986
• MDR Text Key: 201886341
• Report Number: 1038671-2020-00371
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 61 YR