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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 PHA01244
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Information (3190)
Date of Event 04/01/2020
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 felt something clunk or move, took one more step, felt a severe jolt in his groin and fell.X rays showed a right femoral neck fracture at the junction of the femoral stem component with the femoral neck.Records state the fracture caused dislocation and displacement of his hip joint.The fracture was in the femoral neck/stem modular junction.
 
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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 Key10864720
Report Number3010536692-2020-00700
Device Sequence Number14281754
Product Code LWJ
UDI-Device IdentifierM684PHA012441
UDI-PublicM684PHA012441
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2004
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial,Followup
Report Date (Section B) 01/12/2021
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 NumberPHA01244
Device Catalogue NumberPHA01244
Device Lot NumberS04105358X1
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/28/2020
Initial Date Received by Manufacturer 10/28/2020
Supplement Date Received by Manufacturer10/28/2020
Initial Report FDA Received Date11/18/2020
Supplement Report FDA Received Date01/12/2021
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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