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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE(R) PLUS CUP; HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. CONSERVE(R) PLUS CUP; HIP COMPONENT Back to Search Results
Model Number 38XX-XXXX
Device Problem Insufficient Information (3190)
Patient Problem Reaction (2414)
Event Type  Injury  
Event Description
Allegedly, patient revised due to implant loosening and metallosis.(left).
 
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Brand Name
CONSERVE(R) PLUS CUP
Type of Device
HIP 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 Key8191290
MDR Text Key131210608
Report Number3010536692-2018-01557
Device Sequence Number1
Product Code KWA
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 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number38XX-XXXX
Device Catalogue Number38XX-XXXX
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/07/2018
Date Manufacturer Received12/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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