MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	02-012-44-3509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation, the patient had a left knee replacement (b)(6) 2013.Approximately 9 years and 11 months after the initial procedure the patient had a left knee revision due to accelerated and preventable wear.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
H6 :investigation results: the revision reported was likely the result of prosthesis wear, osteolysis, and failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, this cannot be confirmed as there were no details regarding cementing technique or environmental conditions provided and the device, images, and radiographs were not returned for evaluation.These devices are used for treatments, not diagnosis.There is no other information available.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: michael crader ; 3523771140
• MDR Report Key: 16861954
• Report Number: 1038671-2023-00891
• Device Sequence Number: 12251647
• Product Code: JWH
• UDI-Device Identifier: 10885862173591
• UDI-Public: 10885862173591
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2024

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: 01/29/2021
• Device Model Number: 02-012-44-3509
• Device Catalogue Number: 02-012-44-3509
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/11/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2013
• 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: A
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown