MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2.5 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	LOGIC TIBIA PS MOD INSRT SZ 2.5 15MM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 7 yrs postop, this (b)(6) female patient came in three weeks ago to see surgeon on x-ray showed that the right femoral component has moved and went into flexion with significant wear to the insert.Component of loose and inflection and significant wear to the insert.Patient was last known to be in stable condition following the event.The device will be returned.
Additional Manufacturer Narrative
Section d1: brand name.Section d4: model number, catalog number, expiration date, unique identifier (udi) #.Section h4: device manufacture date.
Additional Manufacturer Narrative
After further review of additional information received.(h3) the evaluation noted that revision reported was likely the of aseptic (non-infected) loosening of the femoral component, which damaged the bond between the implant and the bone and likely contributed to wear of the tibial insert.The most probable root cause associated with the reported event of "loosening - femoral" is associated with weakened integration of the device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 2.5 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11448332
• Report Number: 1038671-2021-00100
• Device Sequence Number: 17147380
• Product Code: JWH
• UDI-Device Identifier: 10885862159175
• UDI-Public: 10885862159175
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/30/2020
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 2.5 15MM
• Device Catalogue Number: 02-012-35-2515
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 03/16/2021; 04/16/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 03/28/2021; 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: 66 YR
• Patient Weight: 74