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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL A-CLASS® 48MM FEMORAL HEAD; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL A-CLASS® 48MM FEMORAL HEAD; HIP COMPONENT Back to Search Results
Model Number 38AC4800
Medical Device Problem Codes Material Disintegration (1177); Unstable (1667)
Health Effect - Clinical Code No Code Available (3191)
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 had high cocr levels, the cup was removed without cup cutters.Patient is or was a smoker.
 
Additional Manufacturer Narrative
See attached.- attachment: [wd011615.Pdf].
 
Additional Manufacturer Narrative
Device code corrected.
 
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Brand Name
CONSERVE® TOTAL A-CLASS® 48MM FEMORAL HEAD
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9844802
Report Number3010536692-2020-00245
Device Sequence Number3432574
Product Code JDL
UDI-Device IdentifierM68438AC48001
UDI-PublicM68438AC48001
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K051348
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2020
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date (Section B) 05/20/2020
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 Number38AC4800
Device Catalogue Number38AC4800
Device Lot Number0711389260
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/26/2020
Initial Date Received by Manufacturer 02/26/2020
Supplement Date Received by Manufacturer02/26/2020
02/26/2020
Initial Report FDA Received Date03/17/2020
Supplement Report FDA Received Date03/17/2020
05/20/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age75 YR
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