MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 4 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number 02-012-35-4009

Device Problem Defective Device (2588)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported via clinical study, that postop the initial implant, this 69 yo male patient experienced polyethylene wear with evidence of osteolysis.Moderate effusion.Fixed flexion deformity to 10 to 15 degrees.Osteolysis affecting the medial femoral condyle and the proximal medial tibial plateau to right knee.The patient is listed for revision right total knee replacement.The patient¿s outcome was last known as continuing.The case report form indicates this event is definitely related to device and definitely related to procedure.Devices will not be returned.

Manufacturer Narrative

D10.Concomitants: 02-010-01-0340 logic femoral ps cem right sz 4, 02-012-45-4040 lgc tibial fit tray cem sz 4f / 4t, 200-02-38 three peg patella 38mm.

Manufacturer Narrative

Section h10: (d6b) if explanted, give date: (b)(6) 2023.(h3) the revision reported was likely the result of the reported prosthesis wear, osteolysis, and bone fracture.The tibial insert wear may have been due to malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The bone fracture was likely the result of the patient¿s reported fall.However, this cannot be confirmed because the components were not returned for evaluation and images or radiographs were not provided.Section h11: *the following sections have corrected information: (d1) brand name: logic tibia ps mod insrt sz 4 9mm, (h6) component code: 734, bearings; 7455, part/component/sub-assembly term not applicable.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 4 9MM
• Type of Device: 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 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17581163
• MDR Text Key: 321511072
• Report Number: 1038671-2023-01988
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862001887
• UDI-Public: 10885862001887
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K033883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 02-012-35-4009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 08/19/2023
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 89 KG