MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC TIB INSERT SIZE 4, 19MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CC TIB INSERT SIZE 4, 19MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Hematoma (1884)
Date of Event	08/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: femoral component (cat# 02-010-06-0240).Femoral stem (cat# 02-012-64-1680).Tibial tray (cat# 02-012-45-4040).Femoral augments (distal) (cat# 208-05-04).Tibial stem extension (cat# 02-012-64-1480).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 one-month post ltka, the patient on (b)(6) 2020 clinic visit, subject presented with a hematoma on his left tka, and was placed in a knee immobilizer.At (b)(6) 2020 visit, subject had increased drainage and was scheduled for a revision on (b)(6) 2020 with i&d.This patient has a history of infection in this knee.The event is not related to the device but possibly related to the procedure.Information received from clinical study database.The device will not return due to clinical study policy.Outcome was reported as resolved.No other information available at this time.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) as reported by the exactech knee replacement study, approximately one-month post ltka, the patient 0n (b)(6) 2020 clinic visit, subject presented with a hematoma on his left tka, and was placed in a knee immobilizer.At (b)(6) 2020 visit, subject had increased drainage and was scheduled for a revision on (b)(6) 2020 with i&d.This patient has a history of infection in this knee.The event is not related to the device but possibly related to the procedure.Information received from clinical study database.The device will not return due to clinical study policy.Outcome was reported as resolved.No other information available at this time.Upon review, there is no indication of manufacturing or design issues.The most likely cause of the reported event appears to be the results of the patient conditions, which caused the infection.

• Brand Name: LOGIC CC TIB INSERT SIZE 4, 19MM
• 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: 12584241
• Report Number: 1038671-2021-00520
• Device Sequence Number: 14376490
• Product Code: JWH
• UDI-Device Identifier: 10885862266156
• UDI-Public: 10885862266156
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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 TIB INSERT SIZE 4, 19MM
• Device Catalogue Number: 02-012-65-4019
• 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: 09/17/2021
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 05/25/2022
• 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: Disability; Required Intervention
• Patient Sex: Unknown