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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® TL STEM HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. PROFEMUR® TL STEM HIP COMPONENT Back to Search Results
Model Number PRTL002X
Device Problem Corroded (1131)
Patient Problems Pain (1994); Loss of Range of Motion (2032)
Event Type  Injury  
Manufacturer Narrative
This event will be updated once the investigation is complete. Trends will be evaluated.
 
Event Description
Allegedly, revision surgery necessary due to elevated cobalt ion levels, pain, stiffness, functional impairment and corrosion at the neck-stem junction.
 
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Brand NamePROFEMUR® TL STEM
Type of DeviceHIP 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 Key14225923
MDR Text Key290695681
Report Number3010536692-2022-00147
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPRTL002X
Device Catalogue NumberPRTL002X
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/06/2022
Date Manufacturer Received04/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes

Patient Treatment Data
Date Received: 04/27/2022 Patient Sequence Number: 1
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