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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 Corroded (1131); Material Disintegration (1177)
Health Effect - Clinical Code Toxicity (2333)
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, patient was revised due to corrosion at the metal-metal junction issue at the cocr modular neck and titanium stem.In the revision operative report, dr.(b)(6) noted "there was significant metallosis throughout the hip synovium.".
 
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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 Key10371145
Report Number3010536692-2020-00557
Device Sequence Number2552738
Product Code JDL
UDI-Device IdentifierM684PHAC12041
UDI-PublicM684PHAC12041
Combination Product (Y/N)N
Initial Reporter StateAR
Initial Reporter CountryUS
PMA/510(K) Number
K091423
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2019
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 08/20/2020
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 NumberPHAC1204
Device Catalogue NumberPHAC1204
Device Lot Number030107967210
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/13/2020
Initial Date Received by Manufacturer 07/13/2020
Supplement Date Received by Manufacturer07/13/2020
Initial Report FDA Received Date08/05/2020
Supplement Report FDA Received Date08/20/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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