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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL A-CLASS® 50MM FEMORAL HEAD; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL A-CLASS® 50MM FEMORAL HEAD; HIP COMPONENT Back to Search Results
Model Number 38AC5000
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Reaction (2414)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
See attached.This event was reported under 3010536692-2020-00212.This is an additional component associated to the event.
 
Event or Problem Description
Allegedly, metal on metal, cup may be loose.Cup, head, neck and the neck sleeve were came out.Additional information: right hip.
 
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Brand Name
CONSERVE® TOTAL A-CLASS® 50MM FEMORAL HEAD
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key10075446
Report Number3010536692-2020-00369
Device Sequence Number2848889
Product Code JDL
UDI-Device IdentifierM68438AC50001
UDI-PublicM68438AC50001
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K051348
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2020
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/20/2020
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 Number38AC5000
Device Catalogue Number38AC5000
Device Lot Number0211304894
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/19/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/19/2020
Initial Report FDA Received Date05/20/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age55 YR
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