MAUDE Adverse Event Report: EXACTECH, INC. LOGIC; SEE H10

Model Number	LOGIC FEMORAL PS CEM RIGHT SZ 2.5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer d10: concomittants: serial #: (b)(6), category #: 02-012-35-2511 - logic tibia ps mod insrt sz 2.5 11mm, - recall device serial #: (b)(6), category #: 02-012-35-2509 - logic tibia ps mod insrt sz 2.5 9mm, serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.Serial #: (b)(6), category #: 02-012-45-2515 - lgc tibial fit tray cem sz 2.5f / 1.5t, serial #: (b)(6), category #: 200-02-32 - three peg patella 32mm, serial #: (b)(6), category #: 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 2.5t, serial #: (b)(6), category #: 200-02-32 - three peg patella 32mm, additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 65 yo female patient, initial right knee implanted on (b)(6) 2014, underwent a revision procedure on (b)(6) 2023.The patient complained of pain.A loose femur was indicated.They were revised to a competitor¿s devices.There was no surgical delays or device breakages.The patient was last known to be in stable condition following the event.No device return anticipated due to the hospital will not release the implants.Photos of the affected product and x-ray images were provided.No further information.
Additional Manufacturer Narrative
Upon investigation it has been determined that this is a duplicate complaint.All information will be appropriately reported under mfr# 1038671-2023-00406.

• Brand Name: LOGIC
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16899735
• Report Number: 1038671-2023-00954
• Device Sequence Number: 15149027
• Product Code: JWH
• UDI-Device Identifier: 10885862001221
• UDI-Public: 10885862001221
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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: 04/07/2019
• Device Model Number: LOGIC FEMORAL PS CEM RIGHT SZ 2.5
• Device Catalogue Number: 02-010-01-0325
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female