BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSERT 90-SRK-130212 PS SIZE 2 X 12MM (KNEE)

    MDR report key: 8204376 · Received December 28, 2018

    Report

    Report Number
    1226420-2018-00304
    Event Type
    Injury
    Date Received
    December 28, 2018
    Date of Event
    December 3, 2018
    Report Date
    February 22, 2019
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    JWH
    PMA / PMN Number
    K150496
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS #239503735:BRIEF DESCRIPTION OF COMPLAINT: THE PATIENT WENT IN FOR A BILATERAL REVISION, DUE TO A COMBINATION OF SOFT TISSUE LAXITY AND A RECENT FALL. WHEN THE PATIENT FELL, THE POST ON THE RIGHT KNEE IMPLANT DISLOCATED. THE SURGEON ALSO REPORTED SOFT TISSUE LAXITY IN BOTH KNEES. ON THE RIGHT KNEE THE SURGEON REPLACED A 10MM POLY TO A 16MM POLY. ON THE LEFT KNEE THE SURGEON REPLACED A 12MM POLY TO A 18MM POLY. THE PATIENT ALSO HAS COMORBIDITIES THAT WERE CONTRIBUTING FACTORS (AUTOIMMUNE DISEASE AND LIMITED MOBILITY). THE SURGEON STATED THERE WERE NO ALLEGATION OF PRODUCT DEFICIENCY RELATED TO THE IMPLANT ITSELF. INVESTIGATION CONCLUSION: THE REPORTED ISSUE WAS NOT CONFIRMED. THE DEVICES SHOWED NO SIGNS OF ANY FAILURES. ALL COMPONENTS APPEAR INTACT AND IN PLACE. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    THE PATIENT WENT IN FOR A BILATERAL KNEE REVISION, DUE TO A COMBINATION OF SOFT TISSUE LAXITY AND A RECENT FALL. WHEN THE PATIENT FELL, THE POST ON THE RIGHT KNEE IMPLANT DISLOCATED. THE SURGEON ALSO REPORTED SOFT TISSUE LAXITY IN BOTH KNEES. ON THE RIGHT KNEE THE SURGEON REPLACED A 10MM POLY TO A 16MM POLY. ON THE LEFT KNEE THE SURGEON REPLACED A 12MM POLY TO A 18MM POLY. THE PATIENT ALSO HAS COMORBIDITIES THAT WERE CONTRIBUTING FACTORS (AUTOIMMUNE DISEASE AND LIMITED MOBILITY). THE SURGEON STATED THERE WERE NO ALLEGATION OF PRODUCT DEFICIENCY RELATED TO THE IMPLANT ITSELF. THIS RECORD REPRESENTS THE LEFT KNEE POLY THAT WAS REMOVED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT WENT IN FOR A BILATERAL KNEE REVISION, DUE TO A COMBINATION OF SOFT TISSUE LAXITY AND A RECENT FALL. WHEN THE PATIENT FELL, THE POST ON THE RIGHT KNEE IMPLANT DISLOCATED. THE SURGEON ALSO REPORTED SOFT TISSUE LAXITY IN BOTH KNEES. ON THE RIGHT KNEE THE SURGEON REPLACED A 10MM POLY TO A 16MM POLY. ON THE LEFT KNEE THE SURGEON REPLACED A 12MM POLY TO A 18MM POLY. THE PATIENT ALSO HAS COMORBIDITIES THAT WERE CONTRIBUTING FACTORS (AUTOIMMUNE DISEASE AND LIMITED MOBILITY). THE SURGEON STATED THERE WERE NO ALLEGATION OF PRODUCT DEFICIENCY RELATED TO THE IMPLANT ITSELF. THIS RECORD REPRESENTS THE LEFT KNEE POLY THAT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041185 INSERT 90-SRK-130212 PS SIZE 2 X 12MM (KNEE) PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH MEDTRONIC ADVANCED ENERGY, LLC 90-SRK-130212 XXA1AEM

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention