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U.S. Department of Health and Human Services

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

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MICROPORT ORTHOPEDICS INC. PROFEMUR TAPERED HIP STEM HIP COMPONENT Back to Search Results
Model Number PHA00413
Device Problems Mechanical Problem (1384); Loss of Osseointegration (2408)
Patient Problem Unequal Limb Length (4534)
Event Type  Injury  
Manufacturer Narrative
This event will be updated once the investigation is complete. Trends will be evaluated.
 
Event Description
Allegedly, the patient was revised due to leg length discrepancy of about 4mm on the right side. Radiographic images showed possible loosening of cup and stem. The revision was scheduled to replace the head and neck and possibly the liner. When trying to remove the neck from the stem, it could not be separated. So the stem was also removed. Additional information received on 02/02/2021: revised part and lot numbers were provided as well as the reason for revision, moreover the revision surgery date.
 
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Brand NamePROFEMUR TAPERED HIP 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 Key11357991
MDR Text Key232812116
Report Number3010536692-2021-00098
Device Sequence Number1
Product Code JDL
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,Followup
Report Date 04/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberPHA00413
Device Catalogue NumberPHA00413
Device Lot Number068583404
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/02/2021
Event Location No Information
Date Manufacturer Received02/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/22/2021 Patient Sequence Number: 1
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