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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR NECK A/R 15DG LONG COBALT CHROME; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. PROFEMUR NECK A/R 15DG LONG COBALT CHROME; HIP COMPONENT Back to Search Results
Model Number PHAC1244
Medical Device Problem Code Corroded (1131)
Health Effect - Clinical Codes Pain (1994); Metal Related Pathology (4530)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
 
Event or Problem Description
Allegedly, the patient had a second revision since the cocr modular neck failed.The patient presented pain, elevated cobalt ion levels, adverse tissue reaction and corrosion.
 
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Brand Name
PROFEMUR NECK A/R 15DG LONG COBALT CHROME
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key11703680
Report Number3010536692-2021-00222
Device Sequence Number11622054
Product Code JDI
UDI-Device IdentifierM684PHAC12441
UDI-PublicM684PHAC12441
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
K091423
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2019
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/23/2021
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 NumberPHAC1244
Device Catalogue NumberPHAC1244
Device Lot Number08981578701
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/02/2021
Initial Date Received by Manufacturer 04/02/2021
Supplement Date Received by Manufacturer04/02/2021
Initial Report FDA Received Date04/21/2021
Supplement Report FDA Received Date06/23/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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