MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC FEMORAL SIZE 4, RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CC FEMORAL SIZE 4, RIGHT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: tibial insert (cat# 02-012-65-4017), tibial tray (cat# 02-012-45-4040), tibial stem extension (cat# 02-012-60-1480).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the exactech knee replacement study, approximately eight months post tka, the patient experienced pain and instability.On (b)(6) 2017, patient was squatting down and felt rt.Knee pop forward and dislocated.Patient's knee was manipulated while he was in (b)(6) and was reduced.On (b)(6) 2018, patient continued to have instability and in (b)(6) 2018 the knee was getting worse by giving away and painful.Dr.(b)(6) schedule a revision (b)(6) 2018.The event is possibly related to the device but unlikely related to the procedure.No further information available, it appears the patient left the study.
Additional Manufacturer Narrative
As reported by the exactech knee replacement study, approximately eight months post tka, the patient experienced pain and instability.On 5/17/2017, patient was squatting down and felt rt.Knee pop forward and dislocated.Patient's knee was manipulated while he was in new york and was reduced.On (b)(6) 2018, patient continued to have instability and in (b)(6) 2018 the knee was getting worse by giving away and painful.The surgeon scheduled a revision 12/31/2018.The event is possibly related to the device but unlikely related to the procedure.No further information available, it appears the patient left the study.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.

• Brand Name: LOGIC CC FEMORAL SIZE 4, 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: 12674149
• Report Number: 1038671-2021-00551
• Device Sequence Number: 11122886
• Product Code: JWH
• UDI-Device Identifier: 10885862265722
• UDI-Public: 10885862265722
• 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: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2022

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 4, RIGHT
• Device Catalogue Number: 02-010-06-0340
• 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: 10/04/2021
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Male
• Patient Weight: 134 KG
• Patient Race: White