MAUDE Adverse Event Report: EXACTECH, INC. LGC TIBIAL FIT TRAY CEM SZ 1.5F / 1.5T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-45-1515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930); Scar Tissue (2060); Synovitis (2094); Joint Laxity (4526); Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Medical device site infection (4845)
Date of Event	09/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 30 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, pain, stiffness, buckling, and popping.The patient stated that she was never truly happy with her knee.Post-operatively, and that it had gotten worse in the past year.Prior to revision.A preoperative aspiration was performed, which was concerning for infection, with a positive synovasure and synovial wbc of 11,800, although cultures had shown no growth.Initial surgery and revision surgery operative notes were provided.Findings indicated substantial inflamed and hypertrophic synovial tissue and scar tissue.A posteromedial nondisplaced fracture of the proximal tibia was also discovered once all the cement was extracted.The surgeon performed a right knee irrigation and debridement, removal of right total knee prosthesis, and fabrication and placement of right knee articulating antibiotic spacer.The patient was awakened and sent to the recovery room in stable condition.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10: (b)(6) - 02-010-01-0315 - logic femoral ps cem right sz 1.5; (b)(6) - 02-012-44-1511 - logic tibia implant psc insert, sz 1.5, 11mm; (b)(6) - 204-32-01 - fluted stem extension 11l x 12 mm; (b)(6) - 204-70-00 - tibial stem ext.Screw; (b)(6) - 200-02-29 - three peg patella 29mm.Multiple mdr reports were filed for this event, please see associated report: 1038671-2023-01215.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, d4, g3/g4, h4, h6.Mdr section codes updated/corrected: b, c, e.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, bone fracture and infection 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 and radiographs 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 1.5F / 1.5T
• 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21701630
• Report Number: 1038671-2025-01669
• Device Sequence Number: 7868252
• Product Code: JWH
• UDI-Device Identifier: 10885862167330
• UDI-Public: 10885862167330
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• 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,Followup
• Report Date (Section B): 05/22/2025

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
• Device Expiration Date: 08/13/2025
• Device Catalogue Number: 02-012-45-1515
• 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: 05/02/2023
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/22/2025
• Date Device Manufactured: 08/17/2015
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown