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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR MODULAR FEMORAL NECK; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. PROFEMUR MODULAR FEMORAL NECK; HIP COMPONENT Back to Search Results
Model Number PHA01202
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 12/07/2020
Type of Reportable Event Serious Injury
Event or Problem Description
Allegedly, sudden fracture of the interchangeable neck of a total hip endoprosthesis.We performed an operative revision of the entire femoral part of the endoprosthesis ((b)(6) 2020), after which the patient is still recovering.Jazmp reference number: (b)(4).Additional information received on 12/24/2020 from (b)(6): updating product ids, lot numbers and implant date.
 
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Brand Name
PROFEMUR MODULAR FEMORAL NECK
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key11148523
Report Number3010536692-2021-00011
Device Sequence Number3607232
Product Code LWJ
UDI-Device IdentifierM684PHA012021
UDI-PublicM684PHA012021
Combination Product (Y/N)N
Initial Reporter CountrySI
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source foreign,other
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/11/2021
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 NumberPHA01202
Device Catalogue NumberPHA01202
Device Lot Number1528938
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/24/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/24/2020
Initial Report FDA Received Date01/11/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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