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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR NECK A/R VAR/VAL 1 SHORT COBALT CHROME; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. PROFEMUR NECK A/R VAR/VAL 1 SHORT COBALT CHROME; HIP COMPONENT Back to Search Results
Model Number PHAC1222
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, patient was revised due to corrosion on cocr modular neck.
 
Additional Manufacturer Narrative
Device manufacturers only, 6.Adverse event problem (refer to coding manual), health effect clinical code 4530 added.
 
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Brand Name
PROFEMUR NECK A/R VAR/VAL 1 SHORT COBALT CHROME
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key11697867
Report Number3010536692-2021-00219
Device Sequence Number11674275
Product Code JDL
UDI-Device IdentifierM684PHAC12221
UDI-PublicM684PHAC12221
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
K091423
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
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 NumberPHAC1222
Device Catalogue NumberPHAC1222
Device Lot Number1201184604
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 Date04/20/2021
Supplement Report FDA Received Date06/23/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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