MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA TRAPTRAY CEM SZ 2F/2T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-41-2020
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Scar Tissue (2060); Inadequate Osseointegration (2646); Metal Related Pathology (4530)
Date of Event	08/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: (b)(6) 02-012-44-2009 - logic tibia implant psc insert, sz 2, 9mm (b (6) 02-020-11-0320 - truliant ps cem fem ps cem right sz 2 (b)(6) 200-02-35 - three peg patella 35mm.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 it was reported that approximately 67 months after a right total knee replacement procedure, the patient underwent a revision procedure to address massive poly wear.Revision surgery operative notes were provided.Indication: aseptic loosening in the setting of massive poly wear from recalled implant.Procedure description: it was noted that there was hypertrophic and metallic appearance of the synovium.An examination of the polyethylene liner revealed catastrophic failure of the medial compartment leading to metal on metal articulation.Retractors were placed and the femoral component was removed with minimal bone loss.Next the tibia was presented anteriorly and a thin curved osteotome was used to remove the tibial component.This again was performed with minimal difficulty and minimal bone loss.There was a significant cavitary lesion in the patella that was debrided with a rongeur and curette.The patient was transferred to pacu in stable condition.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, b, e.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and tibial loosening or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.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 TIBIA TRAPTRAY CEM SZ 2F/2T
• 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 32653
• Manufacturer Contact: geoff gannon ; gainesville, FL 32653
• MDR Report Key: 20422969
• Report Number: 1038671-2024-03933
• Device Sequence Number: 8735607
• Product Code: JWH
• UDI-Device Identifier: 10885862003119
• UDI-Public: 10885862003119
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: 07/21/2019
• Device Catalogue Number: 02-012-41-2020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 05/14/2025
• Date Device Manufactured: 07/22/2011
• Is the Device Labeled for Single Use? (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