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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 PHA01204
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Event or Problem Description
Allegedly, patient was revised due to implant fracture stem revision njr number: (b)(4), side: l, primary asa: p2 - mild disease not incapacitating.Additional information provided by will malatesta on 11/23/2020: lot information.Mhra reference no: (b)(4).
 
Additional Manufacturer Narrative
The product information provided at the initial report was later corrected on 11/26/2020 when the information was provided by hospital's records.This report was amended to reflect this change.
 
Event or Problem Description
Allegedly, patient was revised due to implant fracture stem.Revision njr number: (b)(4); side:l; primary asa: p2 - mild disease not incapacitating.Additional information provided by edward caton on 11/26/2020: adding lot numbers.Mhra reference no: (b)(4).
 
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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 Key10913368
Report Number3010536692-2020-00713
Device Sequence Number11484253
Product Code LWJ
UDI-Device IdentifierM684PHA012041
UDI-PublicM684PHA012041
Combination Product (Y/N)N
Initial Reporter CountryGB
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial,Followup
Report Date (Section B) 02/01/2021
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 Other
Device Model NumberPHA01204
Device Catalogue NumberPHA01204
Device Lot Number1001220090
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/23/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/23/2020
Supplement Date Received by Manufacturer11/23/2020
Initial Report FDA Received Date11/27/2020
Supplement Report FDA Received Date02/01/2021
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		Z-2941-2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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