MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIBIA PS MOD INSRT SZ 3 15MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the legal team, approximately 4.3 years post initial right tka, the male patient presented with pain and swelling following total knee arthroplasty.The patient has had significant symptoms in this right knee for years, but they continue to worsen.Imaging shows significant osteolysis in both his femur and tibia with well fixed implants.He also has a large effusion.Aspiration of the knee joint on multiple occasions has shown no sign of infection.Patient had a right knee revision where polyethylene liner was removed.There was a small crack in the post of the polyethylene liner but no fracture fragments.There was some visible pitting in the polyethylene.There was mild osteolysis of the medial and lateral femoral condyles, however the condyles and epicondyles were intact.There was a large amount of osteolysis in the tibial plateau with an area of osteolysis that had broken through the anteromedial cortex as well as an area of osteolysis that had broken through posteriorly.Patient revised to competitor¿s devices.Patient was transferred to the recovery room in stable condition.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information: please disregard this report as it was submitted in error.Event was previously reported under report #1038671-2022-00138.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 3 15MM
• 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: 16738203
• Report Number: 1038671-2023-00683
• Device Sequence Number: 6597693
• Product Code: JWH
• UDI-Device Identifier: 10885862001832
• UDI-Public: 10885862001832
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 3 15MM
• Device Catalogue Number: 02-012-35-3015
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2011
• 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: Female