MAUDE Adverse Event Report: EXACTECH, INC. LOGIC PS TIB INS SZ 3.5 17MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-3517
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by legal, approximately 4.5 years post op the first revision of the left tka, this male patient underwent a second revision and a new optetrak device tibial insert was placed.Reason for the revision was not reported.Upon information and belief, patient required several revision surgeries for issues including but not limited to polyethylene wear, bone loss, osteolysis, instability, and/or component loosening.
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: 4310966, 200-02-41 - three peg patella 41mm.
Additional Manufacturer Narrative
H3: the logic device with serial number 2848378 is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient's condition and revision surgery as related to the devices cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
Through the course of the investigation, it has been discovered that this report is a duplicate of mfr# 1038671-2021-00531.This case and report are to be closed: any additional information and/or investigation findings will be provided on mfr# 1038671-2021-00531.

• Brand Name: LOGIC PS TIB INS SZ 3.5 17MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16478681
• Report Number: 1038671-2023-00343
• Device Sequence Number: 3126842
• Product Code: JWH
• UDI-Device Identifier: 10885862247391
• UDI-Public: 10885862247391
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/22/2023

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: 10/22/2021
• Device Catalogue Number: 02-012-35-3517
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 02/17/2023; 11/22/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 06/19/2023; 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2013
• 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-0021-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male