BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4906161 · Received July 10, 2015

    Report

    Report Number
    0002249697-2015-02292
    Event Type
    Injury
    Date Received
    July 10, 2015
    Date of Event
    June 16, 2015
    Report Date
    June 16, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS A KRH POLY. THE FOLLOWING DEVICE WAS ALSO LISTED IN THIS REPORT: UNKNOWN KRH BUMPER; CAT# UNKNOWN; LOT# UNKNOWN. UNKNOWN KRH AXLE; CAT# UNKNOWN; LOT# UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION DUE TO REMOVAL OF CYST FROM PATELLA REGION INVOLVING A KRH INSERT WAS REPORTED. THE EVENT WAS CONFIRMED THROUGH MEDICAL RECORDS PROVIDED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO DEVICES WERE RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: MEDICAL REVIEW INDICATED THAT ALL RELATED TO THE SURGICAL APPROACH USED FOR ARTHROPLASTY IN 1989 AND AS SUCH IS EXCLUSIVELY PROCEDURE-RELATED AS RELATED TO SURGICAL TECHNIQUE. NO PATIENT-RELATED ASPECTS, NO OVERWEIGHT AND NO EVIDENCE FOR DEVICE-RELATED ASPECTS. THERE ARE NO X-RAYS AVAILABLE FOR REVIEW AND AS SUCH MANY DETAILS REMAIN OBSCURE ALTHOUGH FOLLOWING THE INFORMATION FROM THE MEDICAL RECORDS THERE IS NOT THE SLIGHTEST DOUBT THAT ALL PROBLEMS RELATING TO THE REVISION OF THE LEFT TK IN 2015 ARE PROCEDURE-RELATED IN NATURE WITHOUT DEVICE-RELATED ASPECTS. DEVICE HISTORY REVIEW: NOT PERFORMED AS NO LOT INFORMATION WAS PROVIDED. COMPLAINT HISTORY REVIEW: NOT PERFORMED AS NO LOT INFORMATION WAS PROVIDED. CONCLUSIONS: THE MEDICAL REVIEW INDICATES THAT BASED ON THE INFORMATION FROM THE MEDICAL RECORDS, THERE IS NO DOUBT THAT ALL PROBLEMS RELATING TO THE REVISION OF THE LEFT TK IN 2015 ARE PROCEDURE-RELATED IN NATURE WITHOUT DEVICE-RELATED ASPECTS. IT IS NOTED THAT TO GAIN ACCESS TO THE JOINT SPACE, THE KNEE JOINT BEARING COMPONENTS NEED TO BE DISASSEMBLED. IT IS COMMON SURGICAL PRACTICE THAT THESE DISASSEMBLED BEARING COMPONENTS ARE SUBSEQUENTLY REPLACED AS A PRECAUTIONARY MEASURE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT DEVICE INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    REMOVAL OF CYST FROM PATELLA REGION AND POLY/BUMPER/AXLE SWAP.

    Description of Event or Problem · 1

    REMOVAL OF CYST FROM PATELLA REGION AND POLY/BUMPER/AXLE SWAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449857 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention