MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM; SEE H10

Model Number	02-012-48-1509
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10.Concomitants: 4695534, 02-010-03-0315 - logic cr femoral cem, right, sz 1.5; 5545398, 200-02-29 - three peg patella 29mm; 5602889, 02-012-45-1515 - lgc tibial fit tray cem sz 1.5f / 1.5t.H6.Investigation results- the logic device with serial number (b)(6) 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.There is no other information available.
Event or Problem Description
It was reported via legal documentation that a patient had an initial right total knee arthroplasty on (b)(6) 2019 and then approximately 3 years, 10 months later, on (b)(6) 2022, they experienced a revision surgery for unreported reasons.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Upon investigation this has been discovered to be a duplicate case, all new/additional information will be appropriately processed and reported under mfr# 1038671-2023-00740.

• Brand Name: LOGIC CR TIB INSERT SLOPE +, SZ 1.5, 9 MM
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17070863
• Report Number: 1038671-2023-01248
• Device Sequence Number: 6688620
• Product Code: JWH
• UDI-Device Identifier: 10885862144379
• UDI-Public: 10885862144379
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2023

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: 08/16/2019
• Device Model Number: 02-012-48-1509
• Device Catalogue Number: 02-012-48-1509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2014
• 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: Unknown