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U.S. Department of Health and Human Services

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

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EXACTECH, INC. NOVATION ELEMENT-STEM, COLLARLESS W/HA, HIGH OFFSET, SZ 14 Back to Search Results
Model Number 164-02-14
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 06/05/2020
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event 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.
 
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Brand NameNOVATION
Type of DeviceELEMENT-STEM, COLLARLESS W/HA, HIGH OFFSET, SZ 14
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
Manufacturer (Section G)
EXACTECH, INC.
2320 nw 66th ct.
gainesville FL 32653
Manufacturer Contact
kate jacobson
3523782617
MDR Report Key10462626
MDR Text Key205308377
Report Number1038671-2020-00510
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K080980
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number164-02-14
Device Catalogue Number164-02-14
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/12/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/27/2020 Patient Sequence Number: 1
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