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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE TOTAL SHORT NECK SLEEVE ADDED CLEARANCE; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. CONSERVE TOTAL SHORT NECK SLEEVE ADDED CLEARANCE; HIP COMPONENT Back to Search Results
Model Number 38NS0N35
Health Effect - Clinical Codes Unspecified Infection (1930); Pain (1994)
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 pain and infection.Components not revised: dynasty® bf shell primary 58mm group g product id: dbfpgg58 lot number: 1817132 profemur® preserve classic size 9 varus 8dg hip stem product id: pprcle09 lot number: 1793809.
 
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Brand Name
CONSERVE TOTAL SHORT NECK SLEEVE ADDED CLEARANCE
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key11849000
Report Number3010536692-2021-00307
Device Sequence Number4366734
Product Code KXA
UDI-Device IdentifierM68438NS0N351
UDI-PublicM68438NS0N351
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K072656
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 07/16/2021
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 Number38NS0N35
Device Catalogue Number38NS0N35
Device Lot Number1781735
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/27/2021
Initial Date Received by Manufacturer 04/27/2021
Supplement Date Received by Manufacturer04/27/2021
Initial Report FDA Received Date05/19/2021
Supplement Report FDA Received Date07/16/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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