MAUDE Adverse Event Report: EXACTECH, INC. LGC TIBIAL FIT TRAY CEM SZ 4F / 3T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-45-4030
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 244-24-11: optetrak hi-flex tibial insert sz 4 11 mm: serial number (b)(6).H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2022-00964.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.A definitive root cause was unable to be determined; however, the prosthesis wear may have been the result of excessive posterior slope of the tibial tray, malalignment between the femoral and tibial components, third body wear, instability, patient-related conditions, or any combination of these possibilities.An additional contributing factor to the tibial insert damage may have been the result of being packaged in a non-conforming vacuum bag for more than five years.The aseptic (non-infected) tibial loosening may have been the result of an insufficient bond between the tibial tray and the bone.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
It was reported that the patient underwent an initial total knee arthroplasty on the right side.Subsequently, the patient experienced pain.As a result, approximately seven years and ten months post-surgery, the patient underwent a revision.It was noted that the polyethylene implant had significant wear, and the tibial tray was found to be loose.Patient was last known to be in stable condition following the event.No further impact to the patient was reported.No additional information is available.This is report 1 of 2 for this event/patient.

• Brand Name: LGC TIBIAL FIT TRAY CEM SZ 4F / 3T
• 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: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 24913070
• Report Number: 1038671-2026-00447
• Device Sequence Number: 9102621
• Product Code: JWH
• UDI-Device Identifier: 10885862004017
• UDI-Public: 10885862004017
• 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: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: 06/22/2024
• Device Catalogue Number: 02-012-45-4030
• 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: 07/29/2022
• Initial Report FDA Received Date: 04/17/2026
• Date Device Manufactured: 06/24/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male