MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0350
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint effusion (4849)
Date of Event	02/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the exactech knee replacement study, the 67-year-old patient had a right tka on (b)(6) 2015.The patient presented with effusion / lucency - mild effusion and minor lucencies under superior aspect of anterior femoral flange.Inpatient hospitalization for revision surgery to right knee.The outcome of this event is considered resolved and the report indicates that the action taken is revision on (b)(6) 2024.Components are being revised are femoral, patella, tibial insert, tibial tray patient was advised and demonstrated quadriceps strengthening exercises.Advised to minimize use of elasticated support.Review in 2 years time with x-ray.Pt eventually had revision surgery on (b)(6) 2024.The case report form indicates that this event is definitely related to the device and to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
(d10) concomitant device(s): 02-012-35-5011 - logic tibia ps mod insrt sz 5 11mm.02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t.200-03-38 - one peg patella 38mm.(h3) pending evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections g1, g3, g6, h1, h2, h3 and h6 have been updated accordingly.(h3): the revision reported may have been the result of femoral loosening.The aseptic (non-infected) femoral loosening was likely the result of an insufficient bond between the femoral component and the bone.The cause and extent of the loosening cannot be confirmed as radiographs and images were not provided and the revised components were not returned to exactech for evaluation.
Additional Manufacturer Narrative
H6: corrected the following: health effect - clinical code, component code.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18918664
• Report Number: 1038671-2024-00523
• Device Sequence Number: 17885309
• Product Code: JWH
• UDI-Device Identifier: 10885862001269
• UDI-Public: 10885862001269
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2024

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 Catalogue Number: 02-010-01-0350
• 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: 03/01/2024
• Supplement Date Received by Manufacturer: 06/07/2024; 10/02/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 07/18/2024; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Patient Age: 67 YR
• Patient Sex: Unknown
• Patient Weight: 98 KG