MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0350
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 7 years and 6 months after a right total knee replacement procedure, the patient has experienced prosthesis wear, joint effusion, osteolysis, balance problems, ambulation or postural difficulties, discomfort, pain, synovitis.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10 concomitants: 2786487 02-010-01-0350 - optetrak logic femoral component.3660477 02-012-41-5050 - optetrak logic tibial tray.3767275 200-02-38 - optetrak 3 peg patella.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral 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.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 5
• 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: 20641803
• Report Number: 1038671-2024-04317
• Device Sequence Number: 7488640
• Product Code: JWH
• UDI-Device Identifier: 10885862001269
• UDI-Public: 10885862001269
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• 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): 11/08/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2018
• Device Catalogue Number: 02-010-01-0350
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 11/08/2024
• Date Device Manufactured: 08/23/2013
• 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: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male