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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD; HIP COMPONENT Back to Search Results
Model Number 38AM5200
Medical Device Problem Code Corroded (1131)
Health Effect - Clinical Code Insufficient Information (4580)
Type of Reportable Event Malfunction
Event or Problem Description
Allegedly, cocr corrosion claim (10+).Left side.
 
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Brand Name
CONSERVE® A-CLASS® BFH® HEAD
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer Contact
rachael wise
5677 airline road
arlington, TN 38002
9018674771
MDR Report Key17987564
Report Number3010536692-2023-00194
Device Sequence Number17956909
Product Code JDL
UDI-Device IdentifierM68438AM52001
UDI-PublicM68438AM52001
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K051348
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2022
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Other
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/23/2023
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 Health Professional
Device Model Number38AM5200
Device Catalogue Number38AM5200
Device Lot Number17395372
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/28/2023
Initial Report FDA Received Date10/23/2023
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) Yes
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexMale
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