MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately fourteen months post initial right side tka, this (b)(6) male patient had a revision due to infection.Patient had pain and swelling.There was no breakage of the device.There was less than 5 minutes surgical delay/prolongation.No adverse event.Patient was last known to be in stable condition.Rep was unable to obtain x-rays or photos.The device is available for evaluation.
Additional Manufacturer Narrative
Concomitant medical products: lgc tibial fit tray cem sz 4f / 4t (cat# 02-012-45-4040 / (b)(4)), logic cr femoral cem, left, sz 4 (cat# 02-010-03-0240 / (b)(4)), three peg patella 35mm (cat# 200-02-35 / (b)(4)), three peg patella 35mm (cat# 200-02-35 / (b)(4)), logic tib insert impl crc, sz 4, 13mm (cat# 02-012-51-4013 / (b)(4)), lgc tibial fit tray cem sz 4f / 4t (cat# 02-012-45-4040 / (b)(4)), logic cr femoral cem, right, sz 4 (cat# 02-010-03-0340 / (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections d9, g3, g6, h2, h3 and h6 have been updated accordingly.(h3) as reported, approximately fourteen months post initial right side tka, this 64 y/o male patient had a revision due to infection.Patient had pain and swelling.There was no breakage of the device.There was less than 5 minutes surgical delay/prolongation.No adverse event.Patient was last known to be in stable condition.Rep was unable to obtain x-rays or photos.The device was returned.No additional information.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 surgical revision for infection cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.

• Brand Name: LOGIC TIB INSERT IMPL CRC, SZ 4, 9MM
• 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: 13565350
• Report Number: 1038671-2022-00207
• Device Sequence Number: 5947022
• Product Code: JWH
• UDI-Device Identifier: 10885862230485
• UDI-Public: 10885862230485
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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 TIB INSERT IMPL CRC, SZ 4, 9MM
• Device Catalogue Number: 02-012-51-4009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 02/19/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019 THRU 0027-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male