MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR FEMORAL CEM, LEFT, SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	LOGIC CR FEMORAL CEM, LEFT, SZ 3
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Aseptic loosening (4883)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 66 yo female patient, underwent a revision procedure on the left knee, and was revised to a competitor¿s devices.The surgeon noted the poly was loose on the tray, there was no evidence of subsurface delamination, there was no cement found attached to the femoral component when removed, the alignment of primary components appeared fine, the femoral components were loose, the tibial components were well fixed, and there were signs of osteolysis in both the femur and tibia.The patient was last known to be in stable condition following the event.The device is not available for return.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H6: the revision reported may have been the result of an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening and osteolysis.The movement of the tibial insert in the tibial tray may have been the result of backside wear of the tibial insert.However, these allegations cannot be confirmed as the devices were not returned for evaluation, images/radiographs were unable to be obtained, and information regarding the other devices and index surgery date were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d4, h6 - health effect - clinical code, medical device problem code, component code, type of investigation, investigation findings, investigation conclusion and h11.The revision reported may have been the result of an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening and osteolysis.The movement of the tibial insert in the tibial tray may have been the result of backside wear of the tibial insert.However, these allegations cannot be confirmed as the devices were not returned for evaluation, images/radiographs were unable to be obtained, and information regarding the other devices and index surgery date 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 CR FEMORAL CEM, LEFT, SZ 3
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• 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: ashley harris ; 3523771140
• MDR Report Key: 15777562
• Report Number: 1038671-2022-01445
• Device Sequence Number: 5127058
• Product Code: JWH
• UDI-Device Identifier: 10885862158017
• UDI-Public: 10885862158017
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 04/03/2026

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 Model Number: LOGIC CR FEMORAL CEM, LEFT, SZ 3
• Device Catalogue Number: 02-010-03-0230
• 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: 10/18/2022
• Supplement Date Received by Manufacturer: 06/29/2023; 03/31/2026
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 07/05/2023; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 82 KG