MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-012-44-5009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: serial #: (b)(4), category #: 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t, serial #: (b)(4), category #: 02-010-01-0350 - logic femoral ps cem right sz 5, serial #: (b)(4), category #: 200-02-35 - three peg patella 35mm, h7: z-0021-2022.
Event or Problem Description
As reported by legal notification, the patient had an initial right tka on (b)(6) 2014.Over the last two years the patient has experienced swelling and increasing sensation of instability.Findings were polyethylene wear medially and posteriorly, as well as on the post with significant foreign body synovitis debris noted, and undermining of the femoral and tibial components.The patient was revised on (b)(6) 2022.The right leg had a large effusion.Upon entering the joint, the fluid appeared benign.This was cultured and gram stain returned negative.There was significant polyethylene wear, synovitis throughout the knee, proliferative synovitis in the suprapatellar pouch, medial and lateral gutters.The patella was everted.This was debrided and then a systematic resection of the synovium in the suprapatellar pouch, medial and lateral gutters was carried out.The patellar component was well fixed.It was removed and the polyethylene removed to reveal significant wear on the posterior aspects as well as on the post, and evidence of yellowing and whitish crystalline formation in the posterior aspect.The femoral component was undermined although not grossly loose.The tibia was then addressed.There was noted to have erosions under the medial aspect of the tibia due to the polyethylene wear.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of polyethylene wear as stated in the operative notes.The extent and root cause of the polyethylene wear cannot be determined as the device was not returned for evaluation, and images and radiographs were not provided.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16740116
• Report Number: 1038671-2023-00686
• Device Sequence Number: 20543858
• Product Code: JWH
• UDI-Device Identifier: 10885862173713
• UDI-Public: 10885862173713
• 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: 2014
• Device Explanted Year: 2022
• 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): 08/21/2023

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: 10/21/2021
• Device Model Number: 02-012-44-5009
• Device Catalogue Number: 02-012-44-5009
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/23/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2013
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male