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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE II MEDIAL PIVOT TIBIAL INSERT SZ 2 RIGHT; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. ADVANCE II MEDIAL PIVOT TIBIAL INSERT SZ 2 RIGHT; KNEE COMPONENT Back to Search Results
Model Number KIMP212R
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Serious Injury
Event or Problem Description
Allegedly, patient was revised due to other reasons.(b)(4).Side: r.Primary asa: p2 - mild disease not incapacitating.Products not revised: advance primary femoral size 2 right nonporous product id: kftcnp2r lot number: 10352430 advance ii cocr tibia base nonporous sz 2 standard product id: ktccnp20 lot number: 17405021.(b)(6) reference no: (b)(4).
 
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Brand Name
ADVANCE II MEDIAL PIVOT TIBIAL INSERT SZ 2 RIGHT
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key11771426
Report Number3010536692-2021-00272
Device Sequence Number3998285
Product Code JWH
UDI-Device IdentifierM684KIMP212R1
UDI-PublicM684KIMP212R1
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K972770
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2009
Device Explanted Year2018
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/04/2021
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 NumberKIMP212R
Device Catalogue NumberKIMP212R
Device Lot Number017405021
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/22/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/22/2021
Initial Report FDA Received Date05/04/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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