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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® BFH® HEAD 48MM MEDIUM NECK; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. CONSERVE® BFH® HEAD 48MM MEDIUM NECK; HIP COMPONENT Back to Search Results
Model Number 38014800
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Unspecified Infection (1930)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
 
Event or Problem Description
Allegedly the patient was revised due to infection.Revision njr number: (b)(4).Side: l.Primary asa: p2-mild disease not incapacitating.
 
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Brand Name
CONSERVE® BFH® HEAD 48MM MEDIUM NECK
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key8736694
Report Number3010536692-2019-00860
Device Sequence Number1977740
Product Code KWA
UDI-Device IdentifierM684380148001
UDI-PublicM684380148001
Combination Product (Y/N)N
Initial Reporter CountryGB
PMA/510(K) Number
K021349
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 05/15/2020
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
Operator of Device Other
Device Model Number38014800
Device Catalogue Number38014800
Device Lot Number048571505
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/11/2019
Initial Date Received by Manufacturer 06/11/2019
Supplement Date Received by Manufacturer06/11/2019
Initial Report FDA Received Date06/26/2019
Supplement Report FDA Received Date05/15/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age51 YR
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