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

Model Number	LOGIC CC FEMORAL SIZE 4, LEFT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: tibial insert (cat# 02-012-65-4013), tibial tray (cat# 02-012-45-4040), tibial stem extension (cat# 02-012-60-1440), patellar (cat# 200-02-38).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the (b)(6) knee replacement study, approximately 3.5 years post tka, the patient complains that his left knee pops out of place frequently.Phone interview done.Patient will not come into office d/t covid.The event is possibly related to the device or the procedure.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g7, h2, h3 and h6 have been updated accordingly.(h3) as reported by the exactech knee replacement study, approximately 3.5 years post ltka, the patient complains that his left knee pops out of place frequently.Phone interview done.Patient will not come into office d/t covid.The event is possibly related to the device or the procedure.Revision has not been completed and devices remain implanted.Based on review of all available information, there is no evidence to suggest that the reported dislocation and potential revision are related to any design, manufacturing, or patient related issues.The cause of the revision is most likely is related to the patient¿s underlying condition; however, that could not be confirmed.

• Brand Name: LOGIC CC FEMORAL SIZE 4, LEFT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11991471
• Report Number: 1038671-2021-00294
• Device Sequence Number: 4328652
• Product Code: JWH
• UDI-Device Identifier: 10885862265678
• UDI-Public: 10885862265678
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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 Expiration Date: 10/19/2021
• Device Model Number: LOGIC CC FEMORAL SIZE 4, LEFT
• Device Catalogue Number: 02-010-06-0240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 07/26/2021
• 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; Disability
• Patient Age: 57 YR
• Patient Weight: 90