MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM LEFT SZ 2.5; SEE H10

Model Number	02-010-01-0225
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Necrosis (1971); Synovitis (2094)
Date of Event	07/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10.Concomitants: 4311314 02-012-44-2513 - logic tibia implant psc insert, sz 2.5, 13mm.4577722 02-012-41-2525 - logic tibia traptray cem sz 2.5f/2.5t.4638491 200-02-32 - three peg patella 32mm.Pending investigation.There is no other information available.
Event or Problem Description
It was reported via legal documentation that a patient had a left total knee arthroplasty on (b)(6) 2017 and then approximately 5 years, 5 months later was revised on (b)(6) 2022.Revision operative report of (b)(6) 2022-failed left total knee arthroplasty secondary to aseptic patellar and femoral loosening.Revised to competitor¿s devices.Procedure: a complete synovectomy was performed.The polyethylene was removed, there was minimal wear.The patella component was grossly loose, and it appeared there was an old patella fracture with large inferior fragment fibrously united.The femoral component was grossly loose, there was moderate bone resorption and necrosis in the medial femoral condyle.The tibial was loosely affixed and removed without difficulty.Sterile dressings were applied, and the patient was awakened and transferred to the recovery room.No complications.Hospital care: admitted (b)(6) 2022, discharged (b)(6) 2022.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.
Additional Manufacturer Narrative
User-related considerations: there were no user-related issues reported that appear to have contributed to the reported event.Patient-related considerations: there are no patient conditions reported that appear to have contributed to the reported event.The reason for the revision reported cannot be confirmed from the information provided but may be the result of femoral loosening, tibial loosening, patellar loosening, and/or suspected prosthesis wear 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.This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6 clinical code.

• Brand Name: LOGIC FEMORAL PS CEM LEFT SZ 2.5
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17170959
• Report Number: 1038671-2023-01416
• Device Sequence Number: 6574468
• Product Code: JWH
• UDI-Device Identifier: 10885862001139
• UDI-Public: 10885862001139
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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: 07/10/2021
• Device Model Number: 02-010-01-0225
• Device Catalogue Number: 02-010-01-0225
• 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: 05/25/2023
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2016
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female