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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® BFH® HEAD 46MM LONG NECK; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. CONSERVE® BFH® HEAD 46MM LONG NECK; HIP COMPONENT Back to Search Results
Model Number 38014635
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Reaction (2414)
Date of Event 09/22/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
 
Event or Problem Description
Allegedly, broken femoral neck and pseudo tumor.
 
Additional Manufacturer Narrative
See attached.- attachment: [wd011615.Pdf].
 
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Brand Name
CONSERVE® BFH® HEAD 46MM LONG NECK
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9083995
Report Number3010536692-2019-01044
Device Sequence Number16851867
Product Code KWA
UDI-Device IdentifierM684380146351
UDI-PublicM684380146351
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K021349
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 02/17/2020
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 Number38014635
Device Catalogue Number38014635
Device Lot Number126394337
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/19/2019
Initial Date Received by Manufacturer 08/19/2019
Supplement Date Received by Manufacturer08/19/2019
Initial Report FDA Received Date09/18/2019
Supplement Report FDA Received Date02/17/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age50 YR
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