MAUDE Adverse Event Report: EXACTECH, INC. LGC TIBIAL FIT TRAY CEM SZ 6F / 6T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-45-6060
Medical Device Problem Codes	Unstable (1667); Loss of Osseointegration (2408); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	05/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.Related cases: mfr #1038671-2023-00155 report 1 of 3.Report 3 of 3.H11.Additional manufacturer narrative- report 2 of 3.D10.Concomitants: 1332936 204-26-13 - ps tibial inserts sz 6, 13mm 2977817 200-02-41 - three peg patella 41mm 3553937 204-34-04 - fluted stem extension 40l x 14 mm 3703978 204-70-00 - tibial stem ext.Screw 2057579 234-03-06 - optetrak asy,ps cemented femoral, sz 6, h3.The revision reported was likely the result of prosthesis wear, osteolysis, and insufficient bonds between the devices and the bones, which led to aseptic (non-infected) loosening.It is possible that a contributing factor to the reported wear may have been the result of being packaged in a non-conforming bag for more than 5 years before it was implanted.The extent and root cause of the osteolysis, loosening, and prosthesis wear could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.This is considered ¿very low¿ occurrence rate and therefore, this issue does not appear to be design-related.The dhr for this tibial tray was reviewed, and all components were accepted with conformance to the device requirements.The risk documents were reviewed, and the risk is captured.These devices are used for treatment not diagnosis.There is no additional information available.
Event or Problem Description
It was reported via a legal notification, that the patient, underwent an initial right knee replacement surgery and then approximately 5 years 5 months post initial procedure the patient was revised.Revision operative report-preoperative diagnosis: failed right total knee arthroplasty.Findings: massive osteolysis, loose tibial component.There was a tremendous amount of fluid about the knee consistent with known particulate disease and synovitis.There was osteolysis about the femoral implant, there was an are tunneling into the posterolateral femoral condyle, this was debrided.The tibia was grossly loose with a large defect within the medial tibia.There was additional bone loss posterolaterally which created a cortical defect in the posterolateral through which muscle came through.The medial side was absent good bone.The patella was grossly loose and was removed.¿the patient was taken to the postanesthesia care unit in stable condition.He tolerated the procedure well.There were no immediate complications.¿ there is no additional information available.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, tibial loosening, and patellar loosening.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.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 6F / 6T
• 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 ; 3523771140
• MDR Report Key: 19629522
• Report Number: 1038671-2024-02186
• Device Sequence Number: 12929930
• Product Code: JWH
• UDI-Device Identifier: 10885862004086
• UDI-Public: 10885862004086
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 2020
• 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): 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/22/2023
• Device Catalogue Number: 02-012-45-6060
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 01/28/2025
• Date Device Manufactured: 07/25/2013
• 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
• Patient Age: 70 YR
• Patient Sex: Male