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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® COCR NECK HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. PROFEMUR® COCR NECK HIP COMPONENT Back to Search Results
Model Number PHAC-1252
Device Problem Corroded (1131)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
This complaint will be updated once the investigation is complete. Trends will be evaluated.
 
Event Description
Allegedly the patient was revised due to metallosis. Dr. (b)(6) considered the corrosion on the neck/stem junction indicates a complete removal of the stem. The cup was well positioned so she put in a zbo stem and head and replaced the liner. The following component have no alleged deficiency and were not revised during this surgery: dynasty® bf shell primary, dbfpgg58, lot # 1657019, qty. 1.
 
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Brand NamePROFEMUR® COCR NECK
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 Key8196398
MDR Text Key131405202
Report Number3010536692-2018-01561
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberPHAC-1252
Device Catalogue NumberPHAC-1252
Device Lot Number1656757
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/04/2018
Event Location No Information
Date Manufacturer Received12/07/2018
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: 12/26/2018 Patient Sequence Number: 1
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