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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE A-CLASS BFH HEAD LONG NECK 36MM; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. CONSERVE A-CLASS BFH HEAD LONG NECK 36MM; HIP COMPONENT Back to Search Results
Model Number 38AM3635
Medical Device Problem Code Material Disintegration (1177)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluate.
 
Event or Problem Description
Allegedly, patient was revised due to corrosion at the cocr modular neck and titanium stem, elevated cobalt ions levels and loosening of the acetabular component.
 
Additional Manufacturer Narrative
Update lot information.
 
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Brand Name
CONSERVE A-CLASS BFH HEAD LONG NECK 36MM
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9758278
Report Number3010536692-2020-00159
Device Sequence Number16845827
Product Code KWA
UDI-Device IdentifierM68438AM36351
UDI-PublicM68438AM36351
Combination Product (Y/N)N
Initial Reporter StateWV
Initial Reporter CountryUS
PMA/510(K) Number
K051348
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/10/2020
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 Number38AM3635
Device Catalogue Number38AM3635
Device Lot Number069869336
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/07/2020
Initial Date Received by Manufacturer 02/07/2020
Supplement Date Received by Manufacturer02/07/2020
Initial Report FDA Received Date02/26/2020
Supplement Report FDA Received Date06/10/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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