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

Model Number	LOGIC FEMORAL PS CEM RIGHT SZ 5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
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: 2996509 02-010-01-0250 - logic femoral ps cem left sz 5 1736296 02-012-35-5013 - logic tibia ps mod insrt sz 5 13mm 2951048 02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t 3585943 02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t 3563142 200-02-41 - three peg patella 41mm 3606553 200-02-41 - three peg patella 41mm 1765968 02-012-35-5015 - logic tibia ps mod insrt sz 5 15mm 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
Related (b)(4) lk rev related (b)(4) r quad dehiscence ******* original 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 case-(b)(4).19 jul 2023 / a cyburt - additional information; legal short, revision op report, right quad op report received via legal on 28-jun-2023 as reported via legal documentation, a patient had bilateral knee replacement on (b)(6) 2014.They subsequently underwent right knee revision on (b)(6) 2022, approximately 8 years 5 months post primary procedure.05 dec 2022 op report postoperative diagnosis: failed bilateral total knee arthroplasty secondary to aseptic femoral loosening and polyethylene wear.The right patella was found to be well fixed.The femoral component was easily disimpacted from the intact cement mantle.Tibia was checked and was found to be well fixed.There was a large cyst posterior lateral, which was not decompressed from the arthrotomy.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.Updated info received 09/05/2023 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.
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.
Event or Problem Description
As reported via legal documentation, a patient had bilateral knee replacement on (b)(6) 2014.They subsequently underwent right knee revision on (b)(6) 2022, approximately 8 years 5 months post primary procedure.On (b)(6) 2022 op report postoperative diagnosis: failed bilateral total knee arthroplasty secondary to aseptic femoral loosening and polyethylene wear.The right patella was found to be well fixed.The femoral component was easily disimpacted from the intact cement mantle.Tibia was checked and was found to be well fixed.There was a large cyst posterior lateral, which was not decompressed from the arthrotomy.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.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT 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: 20824216
• Report Number: 1038671-2024-04585
• Device Sequence Number: 7850817
• Product Code: JWH
• UDI-Device Identifier: 10885862001269
• UDI-Public: 10885862001269
• 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): 03/20/2025

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: 07/04/2018
• Device Model Number: LOGIC FEMORAL PS CEM RIGHT SZ 5
• Device Catalogue Number: 02-010-01-0350
• 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: 03/20/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 03/20/2025
• Date Device Manufactured: 07/11/2013
• 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