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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCEPRESS FIT KEEL PRIMARY 15MM X SIZE 2+/3/3+; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. ADVANCEPRESS FIT KEEL PRIMARY 15MM X SIZE 2+/3/3+; KNEE COMPONENT Back to Search Results
Model Number KSPP1534
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Pain (1994)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluate.
 
Event or Problem Description
Allegedly, patient has pain on right knee and on film there appears to be signs of implant loosening.All implants were removed and replaced with odc implants.
 
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Brand Name
ADVANCEPRESS FIT KEEL PRIMARY 15MM X SIZE 2+/3/3+
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key9811926
Report Number3010536692-2020-00200
Device Sequence Number14232822
Product Code JWH
UDI-Device IdentifierM684KSPP15341
UDI-PublicM684KSPP15341
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K061223
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2007
Device Explanted Year2020
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/23/2020
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 NumberKSPP1534
Device Catalogue NumberKSPP1534
Device Lot Number067425455
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/19/2020
Initial Date Received by Manufacturer 02/19/2020
Supplement Date Received by Manufacturer02/19/2020
Initial Report FDA Received Date03/10/2020
Supplement Report FDA Received Date09/23/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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