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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD MEDIUM NECK 42MM; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD MEDIUM NECK 42MM; HIP COMPONENT Back to Search Results
Model Number 38AM4200
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
 
Event or Problem Description
Allegedly, patient revised due to the head separating from the shaft.(patient was not very clear on this).
 
Additional Manufacturer Narrative
Please void this report.Additional information for this incident has made changed the reportability of this incident.This product has no alleged deficiency against this product.This incident is now captured under medwatch 3010536692-2019-00823.The initial report for medwatch 3010536692-2019-00822 should be voided.
 
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Brand Name
CONSERVE® A-CLASS® BFH® HEAD MEDIUM NECK 42MM
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key8708380
Report Number3010536692-2019-00822
Device Sequence Number13975841
Product Code KWA
UDI-Device IdentifierM68438AM42001
UDI-PublicM68438AM42001
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K021349
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 02/06/2020
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 Number38AM4200
Device Catalogue Number38AM4200
Device Lot Number048575649
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/20/2019
Initial Date Received by Manufacturer 05/20/2019
Supplement Date Received by Manufacturer05/20/2019
Initial Report FDA Received Date06/18/2019
Supplement Report FDA Received Date02/06/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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