MAUDE Adverse Event Report: EXACTECH, INC. LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	02-012-45-3535
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the 69 y/o male patient had a left knee replacement on (b)(6) 2014.Approximately 8 years and 9 months after the initial procedure the patient had a left knee revision on (b)(6) 2022.The tibial component was removed, and the remaining cement was then removed from the cut surface of the tibia utilizing a saw, osteotomes and a rongeur.During removal of the tibial component, the posterior condyle of the tibia was fractured in a partial articular pattern but remained stable due to soft tissue attachments.Cement was then removed from the intramedullary canal of the tibia utilizing burr, osteotomes, reverse curettes and pituitary instruments.The fracture was provisionally held with k wires and two lag screws were placed with cancellous 4.0 screws medially and laterally to avoid the tibial component keel and stem.Once the screws were placed, the trial tibia was placed to ensure no obstructions due to the screws.The fracture was stable with this fixation and other fixation options were felt to not be worthwhile given the fracture extent.Fluoroscopy confirmed acceptable fracture alignment and hardware positioning.¿ 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
Pending investigation.D10.Concomitants: (b)(6): 02-012-35-3509 - logic tibia ps mod insrt sz 3.5 9mm.(b)(6): 02-010-01-0235 - logic femoral ps cem left sz 3.5.(b)(6): 200-02-35 - three peg patella 35mm.(b)(6): 201-78-99 - 2pk, schanz pin 4mmx130mmx40mm thrd.
Additional Manufacturer Narrative
Investigation results-the patient experienced a bone fracture during device removal, there is no indication that the device malfunctioned or caused the bone fracture; "during removal of the tibial component, the posterior condyle of the tibia was fractured in a partial articular pattern but remained stable due to soft tissue attachments." it is most likely that the method of device removal contributed to the bone fracture.It is noted in the ifu that: bone quality must be considered to ensure that the prostheses does not subside or migrate; fracture of host bone should also be considered.These devices are used for treatment not diagnosis.There is no additional information available.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesvilee FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 17700639
• Report Number: 1038671-2023-02182
• Device Sequence Number: 7510433
• Product Code: JWH
• UDI-Device Identifier: 10885862003997
• UDI-Public: 10885862003997
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2024

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: 02/04/2024
• 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: 07/25/2023
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male