MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 3.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-010-01-0335
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 7.5 years post op the initial right tka, this 62 y/o female patient was revised due to a loose femur.Patient was last known to be in stable condition following the event.Device's will not be returning.
Additional Manufacturer Narrative
Pending evaluation concomitant device(s): 02-012-44-3511 - logic tibia implant psc insert, sz 3.5, 11mm 2719392.Serial number (b)(4) is confirmed to have been packaged in a vacuum bag that does not contain evoh.02-012-45-3525 - lgc tibial fit tray cem sz 3.5f / 2.5t 3594472.200-02-35 - three peg patella 35mm 3808594.
Additional Manufacturer Narrative
Please disregard initial report as this event was found to be a duplicate of event reported under 1038671-2022-00874.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 3.5
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15624819
• Report Number: 1038671-2022-01315
• Device Sequence Number: 12348558
• Product Code: JWH
• UDI-Device Identifier: 10885862001245
• UDI-Public: 10885862001245
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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: 09/15/2019
• Device Model Number: 02-010-01-0335
• Device Catalogue Number: 02-010-01-0335
• 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: 09/26/2022
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female