MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CC FEMORAL SIZE 3, RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number LOGIC CC FEMORAL SIZE 3, RIGHT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348)

Event Date 07/18/2018

Event Type  Injury  

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported by the exactech cc clinical study, approximately three months post tka, the patient went to er because concerned about persistent pain radiating down lateral side of right leg all the way to foot.The event is possible related to the device and the procedure.

Manufacturer Narrative

After further review of additional information received.(h3) as reported by the exactech cc clinical study, approximately three months post tka, the 50 y/o patient went to er because concerned about persistent pain radiating down lateral side of right leg all the way to foot.The patient complained of instability, pain and stiffness.The patient has a history of heart disease, diabetes, and has smoked for 38 years.The patient also has a history of hx breast cancer, copd, asthma, osa, depression.The event is possible related to the device and the procedure.Per ifu#: 700-096-004: postoperative counseling and care is important.It is recommended that regular, long-term postoperative follow-up be undertaken to detect early signs of component wear and loosening, and to consider the course of action to be taken if such events occur.A suitable rehabilitation program should be designed and implemented.A continuing periodic follow-up is recommended.Periodic x-rays should be taken to detect evidence of positional changes, loosening, bone loss, and/or device fracture.In such cases, patients should be monitored, and the benefits of revision surgery should be considered to avoid further deterioration.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the pain and subsequent revision cannot be conclusively determined; however, it is most likely is related to the patient¿s underlying condition.

• Brand Name: LOGIC CC FEMORAL SIZE 3, RIGHT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11193470
• MDR Text Key: 227511021
• Report Number: 1038671-2021-00011
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862265715
• UDI-Public: 10885862265715
• Combination Product (y/n): N
• PMA/PMN Number: K150890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2022
• Device Model Number: LOGIC CC FEMORAL SIZE 3, RIGHT
• Device Catalogue Number: 02-010-06-0330
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Weight: 121