MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR FEMORAL CEM, RIGHT, SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	LOGIC CR FEMORAL CEM, RIGHT, SZ 4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: lgc tibial fit tray cem sz 4f / 4t (cat# 02-012-45-4040 / serial# (b)(4) ) logic cr tib insert std, sz 4, 9mm (cat# 02-012-47-4009 / serial# (b)(4) ) three peg patella 35mm (cat# 200-02-35 / serial# (b)(4) ) as reported, patient presented with pain and extension problem.After checking, surgeon decided to revise the femoral component.Patient was revised to a size 4 ps femur and 9mm ps liner.Patient was last known to be in stable condition following the event.The device will not be returned for analysis as it was discarded by the hospital.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
Event or Problem Description
As reported, patient presented with pain and extension problem.After checking, surgeon decided to revise the femoral component.Patient was revised to a size 4 ps femur and 9mm ps liner.Patient was last known to be in stable condition following the event.The device will not be returned for analysis as it was discarded by the hospital.

• Brand Name: LOGIC CR FEMORAL CEM, RIGHT, SZ 4
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11690438
• Report Number: 1038671-2021-00178
• Device Sequence Number: 16917994
• Product Code: JWH
• UDI-Device Identifier: 10885862158130
• UDI-Public: 10885862158130
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2021

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: 09/21/2026
• Device Model Number: LOGIC CR FEMORAL CEM, RIGHT, SZ 4
• Device Catalogue Number: 02-010-03-0340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/19/2021
• 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: 50 YR