MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	LOGIC FEMORAL PS CEM LEFT SZ 5
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Synovitis (2094); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 02-012-35-5015 - logic tibia ps mod insrt sz 5 15mm.(b)(6) 02-010-01-0350 - logic femoral ps cem right sz 5.(b)(6) 02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t.(b)(6) 02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t.(b)(6) 200-02-41 - three peg patella 41mm.(b)(6) 200-02-41 - three peg patella 41mm.(b)(6) 02-012-35-5013 - logic tibia ps mod insrt sz 5 13mm.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
Legal case: related (b)(4).Related (b)(4).Original description summary: i would like to receive more information on the compensation being offered other than the time missed from work payments.I have double knee replacements scheduled on (b)(6) and i would like to make some decisions on all options available asap.Initial surgery: (b)(6)2014.Refer to (b)(4).Additional information; revision op report & legal short form via legal on (b)(6)2023.As reported via legal documentation the male patient had a bilateral knee replacement on (b)(6) 2014.Approximately 8 years and 5 months after the initial procedure the patient had a bilateral revision on (b)(6) 2022.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2022 diagnosis: failed bilateral knee arthroplasty secondary to aseptic femoral loosening and polyethylene wear.Femoral component was loose with cyst found posterior lateral.Patient was awakened and taken to recovery room in stable condition.(b)(6) 02-012-35-5015 - logic tibia ps mod insrt sz 5 15mm.Serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.Ebi initial surgery attached.Historical record & smartsolve searched for sn/patient name with no results.Update info received from legal (b)(6)2023.Additional information does not alter the reportability assessments or failure mode.New information does not need fu mdr at this time, wait for eng investigation results.
Event or Problem Description
It was reported via legal documentation that approximately 101 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, femoral loosening, joint effusion, and synovitis.Initial surgery and revision surgery operative notes were provided.Patient left the operating room in stable condition.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.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 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20825256
• Report Number: 1038671-2024-04586
• Device Sequence Number: 15632546
• Product Code: JWH
• UDI-Device Identifier: 10885862001177
• UDI-Public: 10885862001177
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

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: 03/16/2019
• Device Model Number: LOGIC FEMORAL PS CEM LEFT SZ 5
• Device Catalogue Number: 02-010-01-0250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2014
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male