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

Catalog Number	02-010-01-0330
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant devices: (b)(6) 204-70-00 - tibial stem ext.Screw (b)(6) 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t (b)(6) 200-02-32 - three peg patella 32mm (b)(6) 02-010-01-0330 - logic femoral ps cem right sz 3 (b)(6) 204-34-02 - fluted stem extension 25l x 14 mm.The product associated with the reported event is within the scope of recall however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.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 ¿ usa (mdl no.3044) patient id: (b)(6) + right knee.9/16/24: additional information received in in-box on 9/11/24.Attached email, initial op report/product id, and revision op report.Revision surgery operative notes were provided.Principal diagnosis: failed right total knee replacement due to polyethylene wear and loosening.History of present illness: (b)(6) is a 63 y.O.Female with a remote history of a right total knee replacement.Patient began having symptoms of right knee pain.Patient has a known implant which does have a recall secondary to polyethylene wear and loosening.The patient had pain with signs and symptoms of loosening.She saw her primary surgeon who recommended revision.With that in mind a had a 2nd opinion with me regarding the pain that she was having.Patient had plain x-ray findings concerning for loosening of the femoral component with some evidence of early polyethylene wear an implant that was only a few years old.Then mind it was felt the patient had aseptic loosening secondary to polyethylene wear given the nature of the implant.Specifics: failed right total knee replacement due to polyethylene wear and loosening.Encountering straw-colored joint fluid upon entry into the joint.Removed the polyethylene insert using a single prong retractor.Inspected and found to have significant pitting as well as erosive changes both medially and laterally with some yellow discoloring noted.Removed the femoral component with minimal bone loss using a retro driver.Used the retro drive to disimpaction tibial base plate.Noted some central bone loss on the tibia and prepared that portion of the bone for cone.The patient was revised to a competitor¿s devices.Complications were none.A sterile bulky dressing was then put into place and the patient was brought out of anesthesia and returned to the recovery room in stable condition.No additional information is available.Original description summary: it was reported via legal documentation that approximately 89 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear.No further issues or complications were reported.No additional information is available." the serial number (b)(6) is confirmed to be a part of recall number: z-0021-2022 02-012-35-3009 - logic tibia ps mod insrt sz 3 9mm serial: (b)(6) 510k: k033883 udi: (b)(4).Product code: jwh x-ray: no operative notes: no concomitant devices: (b)(6) 204-70-00 - tibial stem ext.Screw (b)(6) 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t (b)(6) 200-02-32 - three peg patella 32mm (b)(6) 02-010-01-0330 - logic femoral ps cem right sz 3 (b)(6) 204-34-02 - fluted stem extension 25l x 14 mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available 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 RIGHT SZ 3
• 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 court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 20239577
• Report Number: 1038671-2024-03562
• Device Sequence Number: 20991957
• Product Code: JWH
• UDI-Device Identifier: 10885862001238
• UDI-Public: 10885862001238
• 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: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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: 10/05/2021
• Device Catalogue Number: 02-010-01-0330
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 04/23/2025
• Date Device Manufactured: 10/06/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown