BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3792179 · Received May 6, 2014

    Report

    Report Number
    0002249697-2014-01734
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    October 2, 2013
    Report Date
    October 2, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN 33 X 9 PRESSFIT LEFT PATELLA. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. DISCARDED.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING PATELLA POLY DISASSOCIATION INVOLVING A 33 X 9 PRESSFIT LEFT PATELLA WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICIAN INDICATES THAT THERE IS NO APPARENT CAUSE FOR THE DISASSOCIATION OF THE POLY AND METAL PORTIONS OF THE PATELLA. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED. REVIEW OF THE PROVIDED MEDICAL INFORMATION BY A CLINICIAN INDICATES THAT THERE IS NO APPARENT CAUSE FOR THE PATELLA IMPLANT FAILURE BUT THAT THE PATIENT WAS "NONCOMPLIANT." THE FACT THAT THE PATIENT WAS NONCOMPLIANT COULD HAVE CONTRIBUTED TO THE FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS AN AVID RUNNER AND REPORTED TO CLINIC (B)(6) (2013) COMPLAINING OF A NEW ONSET OF KNEE PAIN, SWELLING, AND A GRINDING SENSATION. EXAM FINDINGS SIGNIFICANT FOR METAL ON METAL CREPITATION. X-RAYS SHOWED A LATERALLY OFFSET LEFT PATELLA INDICATIVE OF A POLY FAILURE AND ELECTED TO PROCEED WITH LEFT PATELLAR REVISION. INTRAOPERATIVELY, THE POLY WAS FOUND NOT ATTACHED TO THE METAL BACK. THE METAL BACK, HOWEVER, WAS SOLIDLY INTEGRATED TO THE BONY SURFACE OF THE PATELLA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS AN AVID RUNNER AND REPORTED TO CLINIC (B)(6) OF THIS YEAR (2013) COMPLAINING OF A NEW ONSET OF KNEE PAIN, SWELLING, AND A GRINDING SENSATION. EXAM FINDINGS SIGNIFICANT FOR METAL ON METAL CREPITATION. X-RAYS SHOWED A LATERALLY OFFSET LEFT PATELLA INDICATIVE OF A POLY FAILURE AND ELECTED TO PROCEED WITH LEFT PATELLAR REVISION. INTRAOPERATIVELY, THE POLY WAS FOUND NOT ATTACHED TO THE METAL BACK. THE METAL BACK, HOWEVER, WAS SOLIDLY INTEGRATED TO THE BONY SURFACE OF THE PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270607 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention