MAUDE Adverse Event Report: EXACTECH, INC. NOVATION; ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 13

Model Number	164-01-13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	10/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): optimus q drill 40mm (cn: 192-072-013, sn: (b)(4)), logical cup - 3 holes, 48mm (cn: 111-12-3348, sn: (b)(4)), bone screw 25mm (cn: 111-12-9125, sn: (b)(4)), bone screw 25mm (cn: 111-12-9125, sn: (b)(4)), femoral head ceramic 32m (cn: 111-152-622, sn: (b)(4)), biolox delta acetabular liner 32/48-50 (cn: 111-22-1005, sn: (b)(4)).
Event or Problem Description
Revision due to proximal fracture.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted in the revision as reported, a patient experienced a revision due to proximal fracture to right hip, due to a fall.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.The most likely cause for the bone fracture was the patient conditions.(d11) concomitant device(s): optimus q drill 40mm (cn: (b)(4),sn: (b)(6).Logical cup - 3 holes, 48mm (cn: (b)(4),sn: (b)(6).Bone screw 25mm(cn: (b)(4),sn: (b)(6).Bone screw 25mm (cn: (b)(4),sn: (b)(6).Femoral head ceramic 32m (cn: (b)(4),sn: (b)(6).Biolox delta acetabular liner 32/48-50 (cn: (b)(4),sn: (b)(6).
Event or Problem Description
As reported, a patient experienced a revision due to proximal fracture to right hip.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.The most likely cause for the bone fracture was the patient conditions.

• Brand Name: NOVATION
• Common Device Name: ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 13
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9279442
• Report Number: 1038671-2019-00562
• Device Sequence Number: 2733956
• Product Code: MEH
• UDI-Device Identifier: 10885862035110
• UDI-Public: 10885862035110
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2020

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: 04/30/2023
• Device Model Number: 164-01-13
• Device Catalogue Number: 164-01-13
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 05/14/2020
• 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