MAUDE Adverse Event Report: EXACTECH, INC. LGC TIBIAL FIT TRAY CEM SZ 3F / 2T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LGC TIBIAL FIT TRAY CEM SZ 3F / 2T
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Joint Laxity (4526)
Date of Event	05/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.D10 concomitants: (b)(6) 02-012-49-3009 - logic cr tib insert slope++, sz 3, 9mm (b)(6) 02-010-03-0330 - logic cr femoral cem, right, sz 3 (b)(6), 1510-s - cemex system fast 70 gm (b)(6) 200-02-32 - three peg patella 32mm (b)(6), 620-00-02 - platelet rich plasma kit with spray tips (b)(6), 620-11-02 - accelerate conc.Sys rep by 620-12-02 (b)(6) sterile disposable containers.
Event or Problem Description
Legal case - usa patient id: deborah arns rk rev case-(b)(4).As reported via legal documentation, this patient had a right total knee arthroplasty on (b)(6) 2012.He had right knee revision on (b)(6) 2017, approximately 4 years 9 months after their initial replacement surgery.Postoperative diagnosis: fractured polyethylene failure with polyethylene debris resulting in severe synovitis.Loose femoral component was present.Post op visit of (b)(6) 2017 patient has resumed all activities without restriction.No instability or pain, has very good range of motion and no other symptoms.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.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, fracture, femoral loosening, and tibial 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 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 3F / 2T
• 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: 21233627
• Report Number: 1038671-2025-00411
• Device Sequence Number: 8630040
• Product Code: JWH
• UDI-Device Identifier: 10885862003959
• UDI-Public: 10885862003959
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• 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): 01/28/2025

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: 07/10/2022
• Device Model Number: LGC TIBIAL FIT TRAY CEM SZ 3F / 2T
• Device Catalogue Number: 02-012-45-3020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/13/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 01/28/2025
• Date Device Manufactured: 07/10/2012
• 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: Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 70 KG