MAUDE Adverse Event Report: EXACTECH, INC. LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-45-3535
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Joint effusion (4849)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a legal notification, that a 69 yo male patient, initial right total arthroplasty in (b)(6) 2016, underwent a revision procedure in (b)(6) 2024, approximately 7 years 10 months post the initial procedure.Since (b)(6) 2023, the patient had suffered from right knee pain: the knee was swollen when he walked for 30 minutes, cycled, stood statically for more than 20 minutes or drove.Taking painkillers and cortisone did nothing to change this situation; the patient lay or sat without being able to do any sport, go out or travel.He could do some limited domestic chores: shopping, housework and gardening.On (b)(6) 2024, the patient consulted his surgeon, who decided to operate on (b)(6) 2024.The surgeon performed a revision of the right total knee prosthesis with an enlarged synovectomy and bone reconstruction.The entire prosthesis was completely replaced by a semi-constrained prosthesis, due to femoral and tibial loosening.The surgeon told the patient that the prosthesis was defective.On discharge, the patient was hospitalized for three weeks at home with dressing and physiotherapy.He resumed driving on (b)(6) 2024, and some activities in (b)(6) 2024.
Additional Manufacturer Narrative
This is 1 of 4 reports.D10: concomittants 200-02-35, three peg patella 35mm, (b)(6).02-012-35-3509, logic tibia ps mod insrt sz 3.5 9mm, (b)(6).02-010-01-0335, logic femoral ps cem right sz 3.5, (b)(6).
Additional Manufacturer Narrative
Report numbers: 1038671-2024-04104, 1038671-2024-04107 and 1038671-2024-04108 this follow-up report is being submitted to relay additional and/or corrected information.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-04104, 1038671-2024-04107 and 1038671-2024-04108.The following sections were updated: h3: device not returned.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, tibial loosening, and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T
• 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 20522681
• Report Number: 1038671-2024-04106
• Device Sequence Number: 8119026
• Product Code: JWH
• UDI-Device Identifier: 10885862003997
• UDI-Public: 10885862003997
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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: 12/01/2025
• Device Catalogue Number: 02-012-45-3535
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2015
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male