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 Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Periprosthetic fracture (4902)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case-usa.Patient id: (b)(6) + right knee.It was reported that during the patient's right knee revision surgery and while removing the tibial component, an intraoperative surgical intervention was performed due to a large section of posterior proximal tibia bone that was adherent to the posterior aspect of the keel creating a fracture defect to the posterior proximal tibia upon removal.It was noted that the large bone fragment contained posterior capsular soft tissue and blood supply and was freed from the tibial component and reapproximated in the anatomic position.It was noted that 70% of the proximal tibia remained intact without compromise and no diaphyseal extension.No additional information is available.Serial no.(b)(6); 02-012-45-3535 - lgc tibial fit tray cem sz 3.5f / 3.5t udi number: (b)(4).510(k) number: k101981 product code: jwh.
Additional Manufacturer Narrative
D10: (b)(4) 02-010-01-0335 - logic femoral ps cem right sz 3.5 (b)(4) 1510-s - cemex system fast 70 gm (b)(4) 200-02-35 -three peg patella 35mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to correct the following field that was entered erroneously in the initial report: g3: 24-feb-2023.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, b, c, e, g.The reason for the reported event was likely due to a periprosthetic bone fracture.The cause of the bone fracture cannot be conclusively determined but may be related to a patient condition, a traumatic event, and/or surgical techniques.However, this cannot be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or 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 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21079664
• Report Number: 1038671-2025-00079
• Device Sequence Number: 8444025
• Product Code: JWH
• UDI-Device Identifier: 10885862003997
• UDI-Public: 10885862003997
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• 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): 08/20/2025

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: 11/29/2022
• Device Catalogue Number: 02-012-45-3535
• 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: 04/10/2023
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2012
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR
• Patient Sex: Female