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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
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Pain (1994)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
 
Event or Problem 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 Name
PROFEMUR® NECK NEUTRAL LONG COBALT CHROME
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key8732927
Report Number3010536692-2019-00855
Device Sequence Number2221048
Product Code JDL
UDI-Device IdentifierM684PHAC12041
UDI-PublicM684PHAC12041
Combination Product (Y/N)N
Initial Reporter CountryGB
PMA/510(K) Number
K091423
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 05/13/2020
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
Operator of Device Other
Device Model NumberPHAC1204
Device Catalogue NumberPHAC1204
Device Lot Number1522564
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/11/2019
Initial Date Received by Manufacturer 06/11/2019
Supplement Date Received by Manufacturer06/11/2019
Initial Report FDA Received Date06/25/2019
Supplement Report FDA Received Date05/13/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age62 YR
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