MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 2.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	LOGIC FEMORAL PS CEM RIGHT SZ 2.5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: three peg patella 32mm (cat# 200-02-32).Lgc tibial fit tray cem sz 2.5f / 2.5t (cat# 02-012-45-2525).Fluted stem extension 25l x 14 mm (cat# 204-34-02).Logic tibia implant psc insert, sz 2.5, 11mm (cat# 02-012-44-2511).Tibial stem ext.Screw (cat# 204-70-00 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 37 months after the initial implant for this (b)(6) y/o female patient, the 2.5 femoral component was replaced due to fracture of the distal femur and was replaced with a cc logic.The patient's fracture of the distal femur was due to a fall.The patient was last known to be in stable condition following the event.The device is not available for evaluation as it was disposed by hospital.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g7, h2, h3 and h6 have been updated accordingly.As reported, approximately 37 months after the initial implant for this 80 y/o female patient, the 2.5 femoral component was replaced due to fracture of the distal femur and was replaced with a cc logic.The patient was last known to be in stable condition following the event.The device is not available for evaluation as it was disposed by hospital.Additional information indicates that the patient's fracture of the distal femur was due to a fall.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the bone fracture was determined to be post traumatic from a fall and is most likely is related to the patient¿s underlying condition.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 2.5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11796921
• Report Number: 1038671-2021-00215
• Device Sequence Number: 11898509
• Product Code: JWH
• UDI-Device Identifier: 10885862001221
• UDI-Public: 10885862001221
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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 Expiration Date: 08/08/2021
• Device Model Number: LOGIC FEMORAL PS CEM RIGHT SZ 2.5
• Device Catalogue Number: 02-010-01-0325
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 80 YR