MAUDE Adverse Event Report: EXACTECH, INC. LGC TIBIAL FIT TRAY CEM SZ 4F / 4T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-45-4040
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060); Osteolysis (2377); Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report number: 1038671-2024-00043, 1038671-2024-05019 d10 concomitants: (b)(6), 02-012-35-4009 - logic tibia ps mod insrt sz 4 9mm.(b)(6), 02-010-01-0240 logic femoral ps cem left sz 4.(b)(6), 200-02-38 - three peg patella 38mm.Other non exactech components.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-00043, 1038671-2024-05019.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and a failure of the cement used to secure the femoral and tibial components, 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, images and radiographs were not provided, and no details regarding cementing technique or environmental conditions were provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6) 2014.Approximately 8 years and 8 months after the initial procedure the patient had a left knee revision on (b)(6) 2022.The patient experienced prosthesis wear, loosening, scar tissue, osteolysis, implant pain and failure of implant.No further issues or complications were reported.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.Revision op report on (b)(6) 2022.Diagnosis: failed left total knee.There was extensive arthrofibrosis and osteolytic debris present.An extensive synovectomy was performed freeing the medial and lateral gutters.An extensive soft tissue sleeve was raised off the medial tibia.The patella button was inspected.It appeared well fixed.There was a moderate amount of plastic loss noted medially.The polyethylene insert separating the tibia and the femur was then removed.There was burnishing and wear noted medially and laterally.Patient awakened, returned from the operating room to the recovery room in stable condition.No additional information is available.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 4F / 4T
• 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 21026934
• Report Number: 1038671-2024-05021
• Device Sequence Number: 13038282
• Product Code: JWH
• UDI-Device Identifier: 10885862004024
• UDI-Public: 10885862004024
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2024

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 Expiration Date: 05/30/2022
• Device Catalogue Number: 02-012-45-4040
• 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: 09/15/2023
• Initial Report FDA Received Date: 12/27/2024
• Date Device Manufactured: 05/31/2012
• 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: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male