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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTIONMP TIB KEELED NONPOR SIZE 6 STANDARD RIG; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. EVOLUTIONMP TIB KEELED NONPOR SIZE 6 STANDARD RIG; KNEE COMPONENT Back to Search Results
Model Number ETPKN6SR
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Insufficient Information (4580)
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 underwent r tkr on (b)(6) 2018.Revised on (b)(6) 2021 due to loosening of the tibia.Revising surgeon was offered mpo's tibial revision option as the femur was not loose and could have stayed in place.Surgeon decided to revise all components with another manufacturer's full revision system.(b)(6).(b)(4).
 
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Brand Name
EVOLUTIONMP TIB KEELED NONPOR SIZE 6 STANDARD RIG
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key12132690
Report Number3010536692-2021-00368
Device Sequence Number17334738
Product Code HRY
UDI-Device IdentifierM684ETPKN6SR1
UDI-PublicM684ETPKN6SR1
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K093552
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2021
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) 09/10/2021
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 NumberETPKN6SR
Device Catalogue NumberETPKN6SR
Device Lot Number1769489
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/20/2021
Initial Date Received by Manufacturer 06/20/2021
Supplement Date Received by Manufacturer06/20/2021
Initial Report FDA Received Date07/07/2021
Supplement Report FDA Received Date09/10/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age52 YR
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