MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	LOGIC FEMORAL PS CEM LEFT SZ 6
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Osteolysis (2377); Inadequate Osseointegration (2646); Joint effusion (4849)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.Concomitant medical products: lgc tibial fit tray cem sz 6f / 5t (cat#: 02-012-45-6050 / serial#: (b)(4)).Logic tibia ps mod insrt sz 6 9mm (cat#: 02-012-35-6009 / serial#: (b)(4)).
Event or Problem Description
As reported, approximately 5 years post the initial implant, this (b)(6) y/o male patient had a left knee revision done based on the femur being loose.The revision was done by a competitor that told the rep that a revision was being done and this manufacturer¿s implants were being removed.The devices will be returned.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
After further review of additional information received the following sections g4, g7, h2, h3 and h6 have been updated accordingly.(h3) the evaluation noted that revision reported was likely the result of an insufficient bond between the femoral component and the bone, which resulted in aseptic (non-infected) femoral loosening.The most probable root cause associated with the reported event is associated with weakened integration of the femoral component at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
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: b, d, e, g.The revision reported may have been due to prosthesis wear, and/or the result of an insufficient bond between the femoral component and the bone, which resulted in aseptic femoral loosening.An additional reason for the reported revision may have been inclusion of the polyethylene in the packaging recall.Prosthesis wear was confirmed on the tibial insert; however, the reported femoral loosening and patellar prosthesis wear could not be confirmed from the provided information.All potential contributions of user and patient-related considerations to the event could not be assessed as the patella component was not available 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 6
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 11362242
• Report Number: 1038671-2021-00063
• Device Sequence Number: 14100787
• Product Code: JWH
• UDI-Device Identifier: 10885862001184
• UDI-Public: 10885862001184
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/10/2025

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: 07/30/2016
• Device Model Number: LOGIC FEMORAL PS CEM LEFT SZ 6
• Device Catalogue Number: 02-010-01-0260
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 02/26/2021; 01/06/2025; 07/09/2025
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 03/10/2021; 01/07/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2011
• 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: Disability; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male