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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. HEAD HIP IMPLANT

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MICROPORT ORTHOPEDICS INC. HEAD HIP IMPLANT Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Reaction (2414)
Event Type  Injury  
Event Description
Allegedly, patient revised due to mom complications.
 
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Brand NameHEAD
Type of DeviceHIP IMPLANT
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 Key7990264
MDR Text Key124512479
Report Number3010536692-2018-01337
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 10/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/24/2018
Event Location No Information
Date Manufacturer Received09/24/2018
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: 10/22/2018 Patient Sequence Number: 1
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