MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; ELEMENT-STEM, COLLARLESS W/HA, HIGH OFFSET, SZ 14

Model Number	164-02-14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	06/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, approximately 16 months postop this (b)(6) y/o female¿s initial right tha, the hip became infected and revised.All total hip devices were removed and insertion of antibiotic spacer.Patient was last known to be in stable condition following the event.Devices were disposed by hospital.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that bassed upon review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.Upon review of all available information, there is no evidence to suggest that a design or manufacturing issue caused or contributed to this event.The reported revision was likely the result of underlying patient factors, which led to the patient¿s infection.

• Brand Name: NOVATION
• Common Device Name: ELEMENT-STEM, COLLARLESS W/HA, HIGH OFFSET, SZ 14
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10462626
• Report Number: 1038671-2020-00510
• Device Sequence Number: 2159926
• Product Code: MEH
• UDI-Device Identifier: 10885862035233
• UDI-Public: 10885862035233
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K080980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

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: 03/08/2023
• Device Model Number: 164-02-14
• Device Catalogue Number: 164-02-14
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 12/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR