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

Catalog Number	02-012-45-2020
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Implant Pain (4561)
Date of Event	08/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report number: 1038671-2023-01669, 1038671-2025-00083 multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-01669, 1038671-2025-00083 d10 concomitants: (b)(6) 02-010-03-0220 - logic cr femoral cem, left sz 2 (b)(6) 02-012-47-2009 - logic cr tib insert std, sz 2, 9mm (b)(6) 200-02-35 - three peg patella 35mm.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, fracture, patellar loosening, and/or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.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.
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6)2018.Approximately 3 years and 4 months after the initial procedure the patient had a left knee revision on (b)(6) 2021.Patient experienced prosthesis wear, fracture, patellar loosening, scar tissue, synovitis, implant pain, osteolysis and failure of implant.There is no other patient demographic or medical history available.Per the revision operative report, ¿the patellar component was loose,¿ and ¿the tibial polyethylene was worn posteriorly and was fractured posteriorly.¿ additionally, there was noted to be ¿wear of the superior posterior aspect of the tibial tray from contact with the femoral component.¿ this indicates that metal-on-metal prosthesis wear was present.It should also be noted that the surgeon ¿felt a revision was necessary to remove all of the osteolysis,¿ and stated that the femoral and tibial components ¿likely would loosen with the amount of osteolysis present.¿ based on this statement, it does not appear that the implants were currently loose, however it does indicate that osteolysis was a substantial reason for revision.The patient was taken to the recovery room in stable condition.There is no device return.There are no photos or other images of the device provided.No additional information is available.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 2F / 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 21080414
• Report Number: 1038671-2025-00085
• Device Sequence Number: 8386167
• Product Code: JWH
• UDI-Device Identifier: 10885862003904
• UDI-Public: 10885862003904
• 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: 2018
• Device Explanted Year: 2021
• 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): 01/06/2025

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 Catalogue Number: 02-012-45-2020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 01/06/2025
• Date Device Manufactured: 03/12/2018
• 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