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

Catalog Number	02-010-01-0250
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 154 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, implant pain and instability.Revision surgery operative notes were provided.Post operative diagnosis noted aseptic loosening, instability.Intraoperatively the surgeon observed an intact patella component but with signs of wear.It was noted that it was elected to explant due to the recall.It was noted the polyethylene was significantly worn with pitting.The surgeon observed the femoral component deboned from its cement mantle, and after removing, observed significant bone loss respective to the lateral condyle.The tibial tray was found to be intact and not loose.No surgical or medical interventions were reported.No additional information is available.
Additional Manufacturer Narrative
D10: (b)(6) 02-012-41-5050 - logic tibia traptray cem sz 5f/5t (b)(6) 02-012-35-5009 - logic tibia ps mod insrt sz 5 9mm the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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 failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and product information 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 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: 21461973
• Report Number: 1038671-2025-01214
• Device Sequence Number: 7680384
• 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: 2011
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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: 08/08/2015
• Device Catalogue Number: 02-010-01-0250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 03/05/2025
• Date Device Manufactured: 08/10/2010
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male