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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® PRIMARY FEMORAL SIZE 3 RIGHT NONPOROUS; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. ADVANCE® PRIMARY FEMORAL SIZE 3 RIGHT NONPOROUS; KNEE COMPONENT Back to Search Results
Model Number KFTCNP3R
Medical Device Problem Codes Unstable (1667); Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
 
Event or Problem Description
Allegedly, patient was revised due to dislocation subluxation; instability; malalignment revision njr number: (b)(6).Side: r.Primary asa: p3 - incapacitating systemic disease.
 
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Brand Name
ADVANCE® PRIMARY FEMORAL SIZE 3 RIGHT NONPOROUS
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key8732937
Report Number3010536692-2019-00842
Device Sequence Number16649597
Product Code JWH
UDI-Device IdentifierM684KFTCNP3R1
UDI-PublicM684KFTCNP3R1
Combination Product (Y/N)N
Initial Reporter CountryGB
PMA/510(K) Number
K972626
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
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) 05/12/2020
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 NumberKFTCNP3R
Device Catalogue NumberKFTCNP3R
Device Lot Number1762277
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/11/2019
Initial Date Received by Manufacturer 06/11/2019
Supplement Date Received by Manufacturer06/11/2019
Initial Report FDA Received Date06/25/2019
Supplement Report FDA Received Date05/12/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age64 YR
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