MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 3 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIBIA PS MOD INSRT SZ 3 11MM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/02/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical studies, exactech knee replacement study, that a 74 yo female patient who was initially implanted on (b)(6) 2012 on the right side for the primary diagnosis of osteoarthritis, had tibial loosening after a fall and underwent a revision approximately 5 years 3 months post the initial implant for mechanical loosening of a tibial component.The case report form indicates this event is possibly related to devices or procedure.The study indicates the event was resolved (b)(6) 2017.
Additional Manufacturer Narrative
No device return anticipated.Concomitant medical products: 02-010-01-0330 - logic femoral ps cem right sz 3, 204-04-33 - trapezoid tibial tray sz 3f/3t, 200-02-38 - three peg patella 38mm, 99 - femoral stem.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review, it was determined there was no reported information indicating the device or procedure may have caused or contributed to the post traumatic event, "tibial loosening after a fall".As there is no written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution, this device issue is not considered a complaint.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 3 11MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15105184
• Report Number: 1038671-2022-00843
• Device Sequence Number: 5213480
• Product Code: JWH
• UDI-Device Identifier: 10885862047663
• UDI-Public: 10885862047663
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2022

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 Model Number: LOGIC TIBIA PS MOD INSRT SZ 3 11MM
• Device Catalogue Number: 02-012-35-3011
• 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: 06/27/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 12/06/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 122 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American