MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 3.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC FEMORAL PS CEM RIGHT SZ 3.5
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	08/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: logic tibia ps mod insrt 02-012-35-3509/4498383.Lgc tibial fit tray cem 02-012-45-3525/4452792, schanz pin, 3mmx145mm 201-78-97/4601877.Upon review of all available information, there is no evidence to suggest that a design or manufacturing issue caused or contributed to this event.The reported arthroscopic procedure was likely the result of underlying patient factors, which led to scar tissue in the knee.
Event or Problem Description
It was reported through the egps clinical study database that a patient underwent arthroscopic surgery for arthrofibrosis and patellar clunk syndrome approximately 9 months post initial implant surgery on her right knee.Both knees, right and the contralateral left, underwent arthroscopic surgery to remove scar tissue about the patella.The study indicated it was possibly related to device and definitely related to the procedure.Outcome indicates resolved.No devices returning as they remain implanted.This report is for the right knee.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 3.5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12737860
• Report Number: 1038671-2021-00570
• Device Sequence Number: 4127042
• Product Code: JWH
• UDI-Device Identifier: 10885862001245
• UDI-Public: 10885862001245
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2021

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
• Operator of Device: Health Professional
• Device Model Number: LOGIC FEMORAL PS CEM RIGHT SZ 3.5
• Device Catalogue Number: 02-010-01-0335
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 72