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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® PRIMARY FEMORAL SIZE 3 LEFT NONPOROUS; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. ADVANCE® PRIMARY FEMORAL SIZE 3 LEFT NONPOROUS; KNEE COMPONENT Back to Search Results
Model Number KFTCNP3L
Medical Device Problem Code Break (1069)
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 during the revision surgery the surgeon found out that the medial posterior condyle of the primary femur component was broken.The exposed metal part became sharped and dug down into the medial side of the insert.
 
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Brand Name
ADVANCE® PRIMARY FEMORAL SIZE 3 LEFT NONPOROUS
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key8865599
Report Number3010536692-2019-01002
Device Sequence Number11451699
Product Code JWH
UDI-Device IdentifierM684KFTCNP3L1
UDI-PublicM684KFTCNP3L1
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K972626
Number of Events Summarized1
Summary Report (Y/N)N
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) 04/17/2020
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 NumberKFTCNP3L
Device Catalogue NumberKFTCNP3L
Device Lot Number06343939
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/18/2019
Initial Date Received by Manufacturer 07/18/2019
Supplement Date Received by Manufacturer07/18/2019
Initial Report FDA Received Date08/06/2019
Supplement Report FDA Received Date04/17/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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