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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK A/R 15DG SHORT COBALT CHROME; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK A/R 15DG SHORT COBALT CHROME; HIP COMPONENT Back to Search Results
Model Number PHAC1242
Medical Device Problem Code Material Disintegration (1177)
Health Effect - Clinical Code No Code Available (3191)
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, patient had high cocr levels, the cup was removed without cup cutters.Patient is or was a smoker.
 
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Brand Name
PROFEMUR® NECK A/R 15DG SHORT COBALT CHROME
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9844998
Report Number3010536692-2020-00251
Device Sequence Number17002320
Product Code JDL
UDI-Device IdentifierM684PHAC12421
UDI-PublicM684PHAC12421
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 Year2012
Device Explanted Year2020
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 05/20/2020
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 NumberPHAC1242
Device Catalogue NumberPHAC1242
Device Lot Number0411330625
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/26/2020
Initial Date Received by Manufacturer 02/26/2020
Supplement Date Received by Manufacturer02/26/2020
Initial Report FDA Received Date03/17/2020
Supplement Report FDA Received Date05/20/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age75 YR
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