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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE BFH HEAD 44MM MEDIUM NECK; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. CONSERVE BFH HEAD 44MM MEDIUM NECK; HIP COMPONENT Back to Search Results
Model Number 38014400
Medical Device Problem Code Material Disintegration (1177)
Health Effect - Clinical Code Reaction (2414)
Type of Reportable Event Serious Injury
Event or Problem Description
Allegedly the patient was experiencing unknown mom complications.Additional information received from legal on 10/01/2019: updating reason for revision and adding implant date , explant date , hospital name , doctor name , products and lot numbers.Allegedly, patient was revised due to adverse tissue reaction to metal debris, corrosion and resultant metal ions.
 
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Brand Name
CONSERVE BFH HEAD 44MM MEDIUM NECK
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key10402389
Report Number3010536692-2020-00574
Device Sequence Number16887886
Product Code KWA
UDI-Device IdentifierM684380144001
UDI-PublicM684380144001
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K021349
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2005
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/13/2020
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 Health Professional
Device Model Number38014400
Device Catalogue Number38014400
Device Lot Number04480855
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/01/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/01/2019
Initial Report FDA Received Date08/13/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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