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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD SHORT NECK 40MM; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD SHORT NECK 40MM; HIP COMPONENT Back to Search Results
Model Number 38AM4004
Medical Device Problem Code Unstable (1667)
Health Effect - Clinical Code Loss of Range of Motion (2032)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
 
Event or Problem Description
Allegedly the patient was revised pain associated with decreased range of motion; difficulty ambulating and instability.(right).Head was removed and replaced with our 28mm +3.5mm head and strykers dual mobility.Cultures taken.
 
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Brand Name
CONSERVE® A-CLASS® BFH® HEAD SHORT NECK 40MM
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key8865597
Report Number3010536692-2019-00989
Device Sequence Number11292521
Product Code KWA
UDI-Device IdentifierM68438AM40041
UDI-PublicM68438AM40041
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K021349
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2009
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 01/28/2020
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 Number38AM4004
Device Catalogue Number38AM4004
Device Lot Number075246820
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/08/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/08/2019
Supplement Date Received by Manufacturer07/08/2019
Initial Report FDA Received Date08/06/2019
Supplement Report FDA Received Date01/28/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age72 YR
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