MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number	02-010-01-0330
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Periprosthetic fracture (4902)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 02-012-35-3011 - logic tibia ps mod insrt sz 3 11mm.02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.200-02-32 - three peg patella 32mm.
Event or Problem Description
Study: exactech knee replacement study; subject: (b)(6).It was reported via clinical study that the 70 yo female patient was admitted to the hospital (b)(6) 2021 due to a low periprosthetic fracture to right total knee replacement.The patient underwent revision surgery on (b)(6) 2021.The patient¿s outcome was last known as resolved (b)(6) 2021.There was no case report form information provided.
Additional Manufacturer Narrative
H3: upon review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.Implantation of a total joint could result pain, fracture, infection, or loosening of total joint hardware.The most likely cause of the reported event was patient conditions.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may be the result of a periprosthetic bone fracture.The cause of the bone fracture cannot be conclusively determined but may be related to a patient condition or unreported traumatic event.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
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: geoff gannon
• MDR Report Key: 16437075
• Report Number: 1038671-2023-00219
• Device Sequence Number: 12594058
• Product Code: JWH
• UDI-Device Identifier: 10885862001238
• UDI-Public: 10885862001238
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2025

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: 02-010-01-0330
• 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: 01/27/2023
• Supplement Date Received by Manufacturer: 06/12/2023; 04/17/2025
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 03/05/2024; 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 86 KG