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	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Ambulation or Postural Difficulties (2544)
Date of Event	03/14/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6) 2013.Approximately 3 years and 2 months after the initial procedure the patient had a left knee revision on (b)(6) 2016.The patient has suffered the following injuries and complications: pain, difficulty with everyday activities, trouble walking.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.Postoperative diagnosis: failed left total knee arthroplasty secondary to aseptic femoral and tibial loosening.Procedure: there is significant hypertrophic inflammatory synovitis a complete synovectomy was performed.On inspection of the components of the patella, component was well fixed.The femoral and tibial components were grossly loose they were extracted there is necrotic bone beneath the components.Residual cement and fibrinous debris was removed.Devices were trialed and then the implants seated.All were assessed and found to be satisfactory.The patient was awakened and transferred to the recovery room.Patient was revised to exactech devices.
Additional Manufacturer Narrative
Report number: 1038671-2023-01970, 1038671-2025-00036 d10 concomitants: optetrak logic (02-012-44-1511, (b)(6).) patella 3 peg (200-02-29, (b)(6).) logic femoral ps cem left sz 1.5 (02-010-01-0215, (b)(6).) multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-01970, 1038671-2025-00036.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, 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 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
• MDR Report Key: 21061313
• Report Number: 1038671-2025-00038
• Device Sequence Number: 8757894
• Product Code: JWH
• UDI-Device Identifier: 10885862167330
• UDI-Public: 10885862167330
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2025

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: 03/05/2022
• Device Catalogue Number: 02-012-45-1515
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 01/02/2025
• Date Device Manufactured: 03/05/2012
• 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: 57 YR
• Patient Sex: Female