MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 15MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products.Logic tibia implant psc insert, sz 3, 15mm (cat#: 02-012-44-3015 / serial#: (b)(4)).Optetrak logic fit tibial tray 3f/3t (cat#: 02-012-45-3039 / serial#: (b)(4)).Three peg patella 29mm (cat#: 200-02-29 / serial#: (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
Approximately 5.5 yr postop the initial implant, this (b)(6) y/o female patient had knee pain soft tissue swelling often on throughout the years.The surgeon had the patient do a nickel allergy test which came back positive for nickel allergy.On (b)(6) 2021 she was revised the knee to s&n oxinium.The femur had a medial tilt that created significant wear medially on the poly insert, as well as notching of the psc spine.The patient is obese and diabetic with rheumatoid arthritis.The devices will be returned.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
After further review of additional information received.(h3) the evaluation noted that revision reported was likely the result of the patient¿s reported nickel allergy.The observed prosthesis wear was likely due to the reported medial tilt of the femoral component which led to a greater amount of force being applied to the medial aspect of the tibial insert as well as internal torsion, subsequently leading to micromotion and increased wear on the medial side.The most probable root cause associated with the reported event of "prosthesis wear" is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.Section d10: concomitant medical products: logic femoral ps cem right sz 3 (cat#: 02-010-01-0330 / serial#: (b)(6), section d1: brand name section d4: model number, catalog number, serial number, expiration date, section h4: device manufacture date.
Additional Manufacturer Narrative
Additional information - b6, b7, d8, d10.H7, & h9.D10.Serial #: (b)(6), category #: 200-02-29 - three peg patella 29mm, serial #: (b)(6), category #: 204-34-02 - fluted stem extension 25l x 14 mm.These devices are used for treatment not diagnosis.No other information is available.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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: 11417277
• Report Number: 1038671-2021-00091
• Device Sequence Number: 3381819
• Product Code: JWH
• UDI-Device Identifier: 10885862173584
• UDI-Public: 10885862173584
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• 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,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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2020
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 15MM
• Device Catalogue Number: 02-012-44-3015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 04/16/2021; 06/28/2023
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/19/2021; 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2012
• 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
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 106 KG