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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR NECK A/R 8DG SHORT COBALT CHROME; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. PROFEMUR NECK A/R 8DG SHORT COBALT CHROME; HIP COMPONENT Back to Search Results
Model Number PHAC1232
Medical Device Problem Code Corroded (1131)
Health Effect - Clinical Code Insufficient Information (4580)
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 of the oblong taper of the profemur® cocr modular neck where it seated in the pocket of the profemur® titanium stem.(left hip).
 
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Brand Name
PROFEMUR NECK A/R 8DG SHORT COBALT CHROME
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key11957465
Report Number3010536692-2021-00322
Device Sequence Number3142067
Product Code JDL
UDI-Device IdentifierM684PHAC12321
UDI-PublicM684PHAC12321
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K091423
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 08/13/2021
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 NumberPHAC1232
Device Catalogue NumberPHAC1232
Device Lot Number1530603
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/24/2021
Initial Date Received by Manufacturer 05/24/2021
Supplement Date Received by Manufacturer05/24/2021
Initial Report FDA Received Date06/08/2021
Supplement Report FDA Received Date08/13/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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