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

Catalog Number	02-012-45-4040
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: 02-010-06-0240 - logic cc femoral size 4, left.02-012-60-1440 - logic stem ext 14mm x 40mm 200-02-29 - three peg patella 29mm.02-012-61-4222 - logic off stm ext 22mm x 120l x 4mm offset.02-010-06-0541 - logic post.Aug.Block size 4, 5mm.208-05-04 - cc distal fem augment sz 4, 5mm.
Event or Problem Description
It was reported via clinical study, that the 52 yo white female patient experienced (tibial implant subsidence/migration) tka tibial comp loosening / subsidence and associated varus deformity.The date of onset is (b)(6) 2022.The patient underwent revision surgery.Indication for revision surgery is aseptic, loosening.The patient¿s outcome was last known as continuing.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, d4, g4, h4, h6.Mdr section codes updated/corrected: a, b, c, d, e, f, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of reported tibial loosening and tibial subsidence.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.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 4F / 4T
• 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 32563
• Manufacturer Contact: geoff gannon
• MDR Report Key: 16541954
• Report Number: 1038671-2023-00436
• Device Sequence Number: 17968310
• Product Code: JWH
• UDI-Device Identifier: 10885862004024
• UDI-Public: 10885862004024
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/04/2026
• 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: 02/15/2023
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Race: White