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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
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Type  Injury  
Event 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).
 
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 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
Type of Device
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key10913368
MDR Text Key218644018
Report Number3010536692-2020-00713
Device Sequence Number1
Product Code LWJ
UDI-Device IdentifierM684PHA012041
UDI-PublicM684PHA012041
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Recall
Type of Report Initial,Followup
Report Date 02/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator 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
Date Manufacturer Received11/23/2020
Removal/Correction NumberZ-2941-2020
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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