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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 Codes Material Disintegration (1177); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Reaction (2414)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluate.
 
Event or Problem Description
Allegedly, mom head was explanted and swapped for our 28mm long ceramic and strykers dual mobility liner.
 
Additional Manufacturer Narrative
Device code corrected.
 
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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 Key9642464
Report Number3010536692-2020-00079
Device Sequence Number2513245
Product Code JDL
UDI-Device IdentifierM684PHAC12041
UDI-PublicM684PHAC12041
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K091423
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2020
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 05/22/2020
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 Number0301099083
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/09/2020
Initial Date Received by Manufacturer 01/09/2020
Supplement Date Received by Manufacturer01/09/2020
Initial Report FDA Received Date01/29/2020
Supplement Report FDA Received Date05/22/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age56 YR
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