MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC FEMORAL SIZE 2, RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	LOGIC CC FEMORAL SIZE 2, RIGHT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: tibial insert (cat# 02-012-65-2015), tibial tray (cat# 02-012-45-2020), tibial stem extension (cat# 02-012-60-1440), and 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, approximately 2.5 yrs postop the initial ltka, the (b)(6) y/o female patient presented with complaints of pain since surgery.The patient stated, ¿knee feels like it is going to give away¿, and she uses a walker as a result.Revision completed.Patient discharged home with home health after 1 day.Devices will not return due to study policy.
Additional Manufacturer Narrative
After further review of additional information received.(h3) as reported, approximately 2.5 yrs postop the initial ltka, the 63 y/o female patient presented with complaints of pain since surgery.The patient stated, ¿knee feels like it is going to give away¿, and she uses a walker as a result.Revision completed.Patient discharged home with home health after 1 day.Devices will not return due to study policy.Upon review of the available information, there is no evidence that this is a device related problem and no allegation against the device.Implantation of a total joint could result pain, infection, loosening of total joint hardware and the patient should monitor their activity and stresses to the operated limb.The most likely cause of the reported event is patient¿s conditions.

• Brand Name: LOGIC CC FEMORAL SIZE 2, RIGHT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11812060
• Report Number: 1038671-2021-00228
• Device Sequence Number: 17085448
• Product Code: JWH
• UDI-Device Identifier: 10885862265708
• UDI-Public: 10885862265708
• 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 Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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: 08/10/2022
• Device Model Number: LOGIC CC FEMORAL SIZE 2, RIGHT
• Device Catalogue Number: 02-010-06-0320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/22/2021
• 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 Weight: 68