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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® Z STEM; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. PROFEMUR® Z STEM; HIP COMPONENT Back to Search Results
Model Number PHA00236
Medical Device Problem Code Insufficient Device Problem Information (3190)
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 evaluated.
 
Event or Problem Description
Allegedly patient was revised due to unknown reasons.Left hip.
 
Additional Manufacturer Narrative
Updated information was received on (b)(6) 2020 that changed the reportability status of this incident.No alleged deficiency against this component.Therefore the event is not reportable.Please void the initial report.
 
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Brand Name
PROFEMUR® Z STEM
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9555143
Report Number3010536692-2020-00022
Device Sequence Number2993426
Product Code LPH
UDI-Device IdentifierM684PHA002361
UDI-PublicM684PHA002361
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 05/21/2020
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 NumberPHA00236
Device Catalogue NumberPHA00236
Device Lot Number1549167
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/09/2019
Initial Date Received by Manufacturer 12/09/2019
Supplement Date Received by Manufacturer12/09/2019
Initial Report FDA Received Date01/06/2020
Supplement Report FDA Received Date05/21/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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