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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR RENAISSANCE STEM; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. PROFEMUR RENAISSANCE STEM; HIP COMPONENT Back to Search Results
Model Number PLS0R411
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Unspecified Tissue Injury (4559)
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 revised due to copious amount of black discolored tissue, black discoloration of the joint capsule consistent with metallosis and dislocation.(left hip).
 
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Brand Name
PROFEMUR RENAISSANCE STEM
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key12178681
Report Number3010536692-2021-00396
Device Sequence Number4712881
Product Code JDL
UDI-Device IdentifierM684PLS0R4111
UDI-PublicM684PLS0R4111
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2019
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) 09/14/2021
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 NumberPLS0R411
Device Catalogue NumberPLS0R411
Device Lot Number0311307520
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/21/2021
Initial Date Received by Manufacturer 06/21/2021
Supplement Date Received by Manufacturer06/21/2021
Initial Report FDA Received Date07/15/2021
Supplement Report FDA Received Date09/14/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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