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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE FEMORAL RESURFACING HEAD 46MM; HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. CONSERVE FEMORAL RESURFACING HEAD 46MM; HIP COMPONENT Back to Search Results
Model Number 38031046
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Event Description
Allegedly, patient was revised due to infection.Revision njr number: 4432449.Side: r.Primary asa: p2 - mild disease not incapacitating.
 
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Brand Name
CONSERVE FEMORAL RESURFACING HEAD 46MM
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 Key10339187
MDR Text Key202740813
Report Number3010536692-2020-00519
Device Sequence Number1
Product Code KXA
UDI-Device IdentifierM684380310461
UDI-PublicM684380310461
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K944752
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number38031046
Device Catalogue Number38031046
Device Lot Number115283555
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/15/2020
Initial Date Manufacturer Received 07/15/2020
Initial Date FDA Received07/29/2020
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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