MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 2.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC FEMORAL PS CEM RIGHT SZ 2.5
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377); Swelling/ Edema (4577)
Date of Event	06/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 64 yo female patient, initial right knee implanted on (b)(6) 2015, underwent a revision procedure on (b)(6) 2023, approximately 8 years post the initial procedure due to instability and osteolysis.The poly and femur were revised.There were no surgical delays or device breakages.The patient was last known to be in stable condition following the event.No device returns anticipated due to the recall.X-rays and photo images were provided.
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitants: 02-012-35-2509 - logic tibia ps mod insrt sz 2.5 9mm- recall device.02-012-45-2515 - lgc tibial fit tray cem sz 2.5f / 1.5t.200-02-32 - three peg patella 32mm 3944817.200-02-32 - three peg patella 32mm 3944847.204-34-02 - fluted stem extension 25l x 14 mm.204-70-00 - tibial stem ext.Screw.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
These devices are used for treatment not diagnosis.Pending investigation.H11.Corrected data -h7 & h9 - the femoral component is not a recalled device.
Event or Problem Description
Update -revision operative report of (b)(6) 2023 postoperative diagnosis: aseptic loosening of right femoral component/premature wear of right poly liner.The patient was revised to exactech devices.No evidence of gross purulence or tissue necrosis, visual inspection revealed severe synovitic changes consistent with polyethene wear disease.The femoral component was grossly loose.Patellar component- well-fixed without evidence of macroscopic wear.Poly demonstrated advanced asymmetric wear involving primarily the medial portion of the component with extensive pitting and delamination.The tibial component demonstrated mild osteolysis surrounding the outer margins of the implant; it was found to be well fixed.The patient was awakened from anesthesia and transferred to her hospital bed and taken to recovery in stable condition.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of prosthesis wear.Additional reasons for the reported revision may be femoral loosening and instability and inclusion of the polyethylene in the packaging recall.However, the reported femoral loosening and instability could not be confirmed from the provided information.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and 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: LOGIC FEMORAL PS CEM RIGHT SZ 2.5
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 17216018
• Report Number: 1038671-2023-01486
• Device Sequence Number: 17688517
• Product Code: JWH
• UDI-Device Identifier: 10885862001221
• UDI-Public: 10885862001221
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2025

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: 05/03/2020
• Device Model Number: LOGIC FEMORAL PS CEM RIGHT SZ 2.5
• Device Catalogue Number: 02-010-01-0325
• 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: 06/08/2023
• Supplement Date Received by Manufacturer: 12/11/2023; 01/21/2025
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 05/09/2024; 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female