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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE II COCR TIBIAL BASE NONPOROUS SZ 2 STANDA; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. ADVANCE II COCR TIBIAL BASE NONPOROUS SZ 2 STANDA; KNEE COMPONENT Back to Search Results
Model Number KTCCNP20
Medical Device Problem Codes Loss of Osseointegration (2408); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Information (3190)
Date of Event 08/24/2020
Type of Reportable Event Serious Injury
Event or Problem Description
Allegedly, tibial insert was found to be loose from the tibial base.Patient had her first revision on (b)(6) 2020, it was captured under incident number: (b)(4).
 
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Brand Name
ADVANCE II COCR TIBIAL BASE NONPOROUS SZ 2 STANDA
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key10961831
Report Number3010536692-2020-00733
Device Sequence Number16280205
Product Code HRY
UDI-Device IdentifierM684KTCCNP201
UDI-PublicM684KTCCNP201
Combination Product (Y/N)N
Initial Reporter StateIA
Initial Reporter CountryUS
PMA/510(K) Number
K960617
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/07/2020
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 Health Professional
Device Model NumberKTCCNP20
Device Catalogue NumberKTCCNP20
Device Lot Number1652034
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/16/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date12/07/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age61 YR
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