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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
Device Problem Output Problem (3005)
Patient Problem Osteolysis (2377)
Event Type  Injury  
Event Description
Allegedly, patient was revised due to lysis-stem/lysis-socket/adverse soft tissue reaction to particulate debris.The cup, head, stem and neck have been revised from patient.Revision njr number: (b)(4), side:r, primary asa: p2 - mild disease not incapacitating.
 
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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
Manufacturer (Section G)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer Contact
5677 airline road
arlington, TN 38002
9018674771
MDR Report Key14377749
MDR Text Key291600136
Report Number3010536692-2022-00191
Device Sequence Number1
Product Code LWJ
UDI-Device IdentifierM684PHA012021
UDI-PublicM684PHA012021
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/12/2022
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
Device Operator Health Professional
Device Model NumberPHA01202
Device Catalogue NumberPHA01202
Device Lot Number048583129
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/22/2022
Initial Date Manufacturer Received 04/22/2022
Initial Date FDA Received05/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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