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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK NEUTRAL LONG COBALT CHROME HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK NEUTRAL LONG COBALT CHROME HIP COMPONENT Back to Search Results
Model Number PHAC1204
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
This event will be updated when investigation is complete.
 
Event Description
Allegedly the patient was revised due to aseptic loosening socket; pain. Microport head, neck and stem were implanted with a competitor's shell and liner. Srnjr number: (b)(6). Side: l. Frasa: p3 incapacitating systematic disease. The following component have no alleged deficiency and were not revised during this surgery: profemur® l hip stem size 2 ha coated pha05504 lot # 1526066 qty. 1.
 
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Brand NamePROFEMUR® NECK NEUTRAL LONG COBALT CHROME
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 Key8732927
MDR Text Key149137856
Report Number3010536692-2019-00855
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K091423
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberPHAC1204
Device Catalogue NumberPHAC1204
Device Lot Number1522564
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/11/2019
Event Location No Information
Date Manufacturer Received06/11/2019
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: 06/25/2019 Patient Sequence Number: 1
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