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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. NOVATION ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 12

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EXACTECH, INC. NOVATION ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 12 Back to Search Results
Catalog Number 164-01-12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Joint Dislocation (2374)
Event Date 11/10/2019
Event Type  Injury  
Event Description
As reported the patient was initially implanted during a left thr on (b)(6) 2019. The patient suffered dislocation while hospitalized for the initial post op period. The patient was taken back to surgery and the left hip was revised. The surgeon ¿went up 2 sizes¿ for the stem with high offset and replaced the femoral head. Reportedly, the patient was last known to be in stable condition following the event.
 
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Brand NameNOVATION
Type of DeviceELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 12
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 Key9368550
MDR Text Key170443899
Report Number1038671-2019-00580
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,Followup
Report Date 02/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number164-01-12
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 Received04/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/08/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/25/2019 Patient Sequence Number: 1
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