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

Model Number	LOGIC CC FEMORAL SIZE 3, LEFT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	06/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: logic stem ext 14mm x 40mm (cat# 02-012-60-1440 / serial# (b)(4)).Tibial stem ext.Screw (cat# 204-70-00 / serial# (b)(4)).Lgc tibia ps rbk insrt sz 3 9mm (cat# 02-012-38-3009 / serial# (b)(4)).Threaded pin size 2.3 collared (cat# 521-78-23 / serial# (b)(4)).Threaded pin size 3.0 collared (cat# 521-78-32 / serial# (b)(4)).Logic post.Aug.Block size 3, 5mm (cat# 02-010-06-0531 / serial# (b)(4)).Lgc tibia rbktray cem sz 3f/ 2t (cat# 02-012-43-3020).Three peg patella 35mm (cat# 200-02-35).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 10 months postop the initial implant, this (b)(6) y/o female patient had a ltka revision due to infection.All implants were removed.Patient was last known to be in stable condition following the event.The device is not available for evaluation as it was disposed by hospital.
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, approximately 10 months postop the initial implant, this 56 y/o female patient had a ltka revision due to infection.All implants were removed.Patient was last known to be in stable condition following the event.The device is not available for evaluation as it was disposed by hospital.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: LOGIC CC FEMORAL SIZE 3, 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: 12089005
• Report Number: 1038671-2021-00318
• Device Sequence Number: 11600070
• Product Code: JWH
• UDI-Device Identifier: 10885862265661
• UDI-Public: 10885862265661
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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: 08/08/2021
• Device Model Number: LOGIC CC FEMORAL SIZE 3, LEFT
• Device Catalogue Number: 02-010-06-0230
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 10/20/2021
• 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 Age: 56 YR