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

Model Number 164-01-13

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Date 10/23/2019

Event Type  Injury  

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 Description

Revision due to proximal fracture.

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 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
• Type of Device: 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
• MDR Text Key: 166330976
• Report Number: 1038671-2019-00562
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 10885862035110
• UDI-Public: 10885862035110
• Combination Product (y/n): N
• PMA/PMN Number: K080980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 10/23/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 05/08/2020
• Supplement Dates FDA Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention