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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® PRESERVE STEM SIZE 6 HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. PROFEMUR® PRESERVE STEM SIZE 6 HIP COMPONENT Back to Search Results
Model Number PRPR0006
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 07/15/2019
Event Type  Injury  
Manufacturer Narrative
This event will be updated when investigation is complete.
 
Event Description
Allegedly breakage of straight femoral stem.
 
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Brand NamePROFEMUR® PRESERVE STEM SIZE 6
Type of DeviceHIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer (Section G)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer Contact
5677 airline road
arlington, TN 38002
9018674771
MDR Report Key8928692
MDR Text Key155480876
Report Number3010536692-2019-01019
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K112080
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberPRPR0006
Device Catalogue NumberPRPR0006
Device Lot Number1406153
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/25/2019
Event Location No Information
Date Manufacturer Received07/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/24/2019 Patient Sequence Number: 1
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