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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE STEMMED MEDIAL PIVOT NONPOROUS FEMORAL SI; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. ADVANCE STEMMED MEDIAL PIVOT NONPOROUS FEMORAL SI; KNEE COMPONENT Back to Search Results
Model Number KFSCNP4L
Medical Device Problem Codes Unstable (1667); Loss of Osseointegration (2408)
Health Effect - Clinical Code Pain (1994)
Type of Reportable Event Serious Injury
Event or Problem Description
Allegedly, the patient suffered pain and instability; loosening of femur and stem.(left knee) component not revised: advance® ii modular titanium tibial base sz 4 std / product id: kttinp40 / lot number: 085268636.
 
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Brand Name
ADVANCE STEMMED MEDIAL PIVOT NONPOROUS FEMORAL SI
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key11210369
Report Number3010536692-2021-00032
Device Sequence Number3526786
Product Code JWH
UDI-Device IdentifierM684KFSCNP4L1
UDI-PublicM684KFSCNP4L1
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K972626
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2006
Device Explanted Year2010
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source distributor,health profession
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/21/2021
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 Health Professional
Device Model NumberKFSCNP4L
Device Catalogue NumberKFSCNP4L
Device Lot Number115290500
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/29/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/29/2020
Initial Report FDA Received Date01/21/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age63 YR
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