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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTIONMP TIB KEELED NONPOR SIZE 4 STANDARD RIG; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. EVOLUTIONMP TIB KEELED NONPOR SIZE 4 STANDARD RIG; KNEE COMPONENT Back to Search Results
Model Number ETPKN4SR
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 12/11/2017
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
Sae # (b)(4): allegedly, the patient had a luxation of the right hip with periprosthetic fracture.Joint reduction performed on (b)(6) 2017.Sae #(b)(4): allegedly, patient sat on the sofa.When lifting the right leg, the hip luxated.Recovered after removing head and modular neck of the right hip.Bfarm case number:(b)(4).
 
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Brand Name
EVOLUTIONMP TIB KEELED NONPOR SIZE 4 STANDARD RIG
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key12070420
Report Number3010536692-2021-00341
Device Sequence Number4541529
Product Code HRY
UDI-Device IdentifierM684ETPKN4SR1
UDI-PublicM684ETPKN4SR1
Combination Product (Y/N)N
Initial Reporter StateLA
Initial Reporter CountryUS
PMA/510(K) Number
K093552
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 08/26/2021
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 NumberETPKN4SR
Device Catalogue NumberETPKN4SR
Device Lot Number1613453
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/03/2021
Initial Date Received by Manufacturer 06/03/2021
Supplement Date Received by Manufacturer06/03/2021
Initial Report FDA Received Date06/25/2021
Supplement Report FDA Received Date08/26/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age69 YR
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