MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA TRAPTRAY CEM SZ 3F/3T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-41-3030
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Implant Pain (4561)
Date of Event	11/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant devices: 02-012-44-3011 - logic tibia implant psc insert, sz 3, 11mm serial number unknown 02-010-01-0330 - logic femoral ps cem right sz 3 serial number unknown 200-02-32 - three peg patella 32mm serial number unknown.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
It was reported that approximately 18 months after a right total knee replacement procedure, the patient underwent a revision procedure to address loosening and bone fracture.Revision surgery operative notes were provided and confirmed that there was bonding of the tibial implant at the keel, but was not fixed at the level of the tibial resection.Evidence of stress shielding was noticed.Revision implants were placed.Patient left the operating room in stable condition.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, tibial loosening and bone fracture.Or due to inclusion of the polyethylene in the packaging recall.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.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: LOGIC TIBIA TRAPTRAY CEM SZ 3F/3T
• 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 FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19366298
• Report Number: 1038671-2024-01377
• Device Sequence Number: 11704663
• Product Code: JWH
• UDI-Device Identifier: 10885862003171
• UDI-Public: 10885862003171
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 02-012-41-3030
• 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: 05/09/2024
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 04/24/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Unknown