MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC FEMORAL SIZE 5, RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CC FEMORAL SIZE 5, RIGHT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: tibial insert, (cat# 02-012-65-5021).Tibial tray, (cat# 02-012-45-5040).Patella, (cat# 208-05-05).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported by the exactech knee replacement study, approximately four years post rtka, the approximately (b)(6) year old male patient complaints of micromovements upon walking and severe pain within six months after his revision in (b)(6) 2016.The event is possibly related to the device but unlikely related to the procedure.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) it was reported by the exactech knee replacement study, approximately four years post rtka, the approximately 78-year-old male patient complaints of micromovements upon walking and severe pain within six months after his revision in (b)(6) 2016.The event is possibly related to the device but unlikely related to the procedure.Devices do not return per the clinical study policy.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 revision was likely the result of underlying patient factors, which led to instability of the joint and pain.

• Brand Name: LOGIC CC FEMORAL SIZE 5, RIGHT
• Common Device Name: 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 12636795
• Report Number: 1038671-2021-00536
• Device Sequence Number: 7116091
• Product Code: JWH
• UDI-Device Identifier: 10885862265739
• UDI-Public: 10885862265739
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2022

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 CC FEMORAL SIZE 5, RIGHT
• Device Catalogue Number: 02-010-06-0350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Race: White