MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 1; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC FEMORAL PS CEM LEFT SZ 1
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Cyst(s) (1800); Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the legal brief, on or about (b)(6) 2012, patient underwent a left total knee arthroplasty due to osteoarthritis in her left knee.In approximately (b)(6) 2022, patient presented to hospital for an evaluation of her left knee, as she had been complaining of mechanical complications and chronic pain.On or about (b)(6) 2022, patient underwent revision surgery of her left knee due to implant loosening and significant synovitis.
Additional Manufacturer Narrative
Concomitant medical products: logic tibia traptray cem sz 1f/1t (cat# 02-012-41-1010 / serial# (b)(4).Three peg patella 32mm (cat# 200-02-32 / serial# (b)(4).Logic tibia implant psc insert, sz 1, 9mm (cat# 02-012-44-1009 / serial# (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H6: investigation results - the revision reported was likely the report of prosthesis wear and an insufficient bond between the implants and the bone, which led to aseptic (non-infected) loosening.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear and loosening could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.
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 revision reported was likely the report of prosthesis wear and an insufficient bond between the implants and the bone, which led to aseptic (non-infected) loosening.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear and loosening could not be determined as the devices were not returned for evaluation, and images 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 1
• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16444020
• Report Number: 1038671-2023-00241
• Device Sequence Number: 5872564
• Product Code: JWH
• UDI-Device Identifier: 10885862001115
• UDI-Public: 10885862001115
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/18/2025

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: 05/06/2015
• Device Model Number: LOGIC FEMORAL PS CEM LEFT SZ 1
• Device Catalogue Number: 02-010-01-0210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 11/01/2023; 02/27/2025; 03/17/2025
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 11/09/2023; 03/03/2025; 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2010
• 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 Sex: Female