BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL KNEE REPLACEMENT

    MDR report key: 6095363 · Received November 11, 2016

    Report

    Report Number
    3004105610-2016-00105
    Event Type
    Injury
    Date Received
    November 11, 2016
    Report Date
    October 20, 2016
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K120992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW PRESCRIPTION FOR A REVISION SURGERY HAS BEEN RECEIVED. THE DATE FOR THE REVISION SURGERY IS NOT YET KNOWN. FURTHER INFORMATION HAS BEEN REQUESTED FROM THE SURGEON IN ORDER TO IDENTIFY THE CAUSE OF THE EVENT. YET KNOWN. THE INVESTIGATION IS ONGOING; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS IN REFERENCE TO AN EXTRA SMALL SMILES TOTAL KNEE REPLACEMENT REVISION SURGERY FOR A NON STANMORE IMPLANTS WORLDWIDE (SIW) IMPLANT. THE REVISION IMPLANT PIN (B)(4) WAS THE FIRST SIW IMPLANT SUPPLIED FOR THE RIGHT KNEE OF THE PATIENT. THE PATIENT HAD PREVIOUSLY RECEIVED AN SIW TOTAL HIP REPLACEMENT AND A LEFT TOTAL KNEE REPLACEMENT, NOT RELATED TO THE ISSUES OF THIS EVENT. AS THE EVENT PERTAINS TO THE REVISION OF A NON-SIW IMPLANT THIS IS A NON-VALID COMPLAINT. ALTHOUGH AN INITIAL MDR REPORT WAS SUBMITTED WITH THE INFORMATION AVAILABLE AT THE TIME OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THEY WERE NOT REQUIRED AS THIS IS THE REVISION OF A NON-SIW IMPLANT. A FINAL MDR SUBMISSION WILL BE FILED TO FULFIL REGULATORY OBLIGATIONS AND TO CLOSE THIS NON-VALID COMPLAINT.

    Description of Event or Problem · 1

    A PRESCRIPTION FORM HAS BEEN RECEIVED FOR A REVISION SURGERY. (B)(4).

    Description of Event or Problem · 1

    A PRESCRIPTION FORM HAS BEEN RECEIVED FOR A REVISION SURGERY. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2016-00105 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747635 TOTAL KNEE REPLACEMENT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention