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

Model Number	LOGIC FEMORAL PS CEM LEFT SZ 3
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Implant Pain (4561)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products: - logic tibia implant psc insert, sz 3, 11mm (cat# 02-012-44-3011 / serial# (b)(6) - z-0021-2022) - lgc tibial fit tray cem sz 3f / 3t (cat# 02-012-45-3030 / serial# (b)(6)) - three peg patella 32mm (cat# 200-02-32 / serial# (b)(6)) - fluted stem extension 40l x 14 mm (cat# 204-34-04 / serial# (b)(6)) - tibial stem ext.Screw (cat# 204-70-00 / serial# (b)(6)) additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that the 66 y/o female patient's left knee was revised approximately 3 years post op.Patient had fallen and was having pain with knee.The 11mm size 3 liner and 32mm patella were removed and while inspecting the prosthesis the femoral component had become loose.The surgeon recemented a new femoral component and implanted an 11mm psc size 3 implant and 35mm patella.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.Sales rep was unable to obtain x-rays.The devices are not available for evaluation due to the devices were discarded at the hospital.
Additional Manufacturer Narrative
H3: the revision reported was likely due to prosthesis wear that resulted from malalignment between the femoral and tibial components and an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.The reported femoral loosening may have been a result of the reported fall, but this cannot be confirmed.Additionally, a contributing factor to the wear of the tibial insert may have been the result of being packaged in a non-conforming vacuum bag for more than five years.However, the extent and likely cause of the prosthesis wear and femoral loosening could not be confirmed as the devices were not returned for evaluation and radiographs were not provided.*the following sections have corrected information: h6: component code, type of investigation, investigation findings, investigation conclusion.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: e.The revision reported was likely due to prosthesis wear that resulted from malalignment between the femoral and tibial components and an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.The reported femoral loosening may have been a result of the reported fall, but this cannot be confirmed.Additionally, a contributing factor to the wear of the tibial insert may have been the result of being packaged in a non-conforming vacuum bag for more than five years.However, the extent and likely cause of the prosthesis wear and femoral loosening could not be confirmed as the devices were not returned for evaluation 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: LOGIC FEMORAL PS 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: geoff gannon
• MDR Report Key: 19259160
• Report Number: 1038671-2024-01079
• Device Sequence Number: 6614862
• Product Code: JWH
• UDI-Device Identifier: 10885862001146
• UDI-Public: 10885862001146
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2024
• Device Model Number: LOGIC FEMORAL PS CEM LEFT SZ 3
• Device Catalogue Number: 02-010-01-0230
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 08/09/2024; 05/07/2025
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 08/27/2024; 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2019
• 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: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female