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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 Corroded (1131)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Event or Problem Description
Allegedly, patient was revised due to corrosion at the neck-stem junction.Left hip components not revised: dynasty® a-class® 36mm 15dg group d crosslinked po product number: dlxpld36 lot batch : 1291016120.Dynasty® bf shell 52mm group d product number: dsbfgd52 lot batch : 03098098001.Cancellous self-tapping 6.5mm bone screw 4.0cm len po product number: 18080305 lot batch : 0201048277.Cancellous self-tapping 6.5mm bone screw 3.0cm len po product number: 18080303 lot batch : 089926687.
 
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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 Key10870364
Report Number3010536692-2020-00701
Device Sequence Number3315812
Product Code LWJ
UDI-Device IdentifierM684PHA012021
UDI-PublicM684PHA012021
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/19/2020
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 NumberPHA01202
Device Catalogue NumberPHA01202
Device Lot Number0201047146
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/29/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/29/2020
Initial Report FDA Received Date11/19/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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