BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22MM TRIAL RADIAL HEAD 4MM HT EXTENSION/16.5MM

    MDR report key: 3083417 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10997
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWI
    PMA / PMN Number
    K112030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. PRODUCT DEVELOPMENT EVALUATION REVEALS, THE PART WAS NOT RETURNED FOR INSPECTION. THE TRAIL HEADS ARE USED TO EVALUATE WHICH IMPLANT SIZE, IN BOTH HEIGHT AND DIAMETER, SHOULD BE USED FOR EACH PATIENT DUE TO THE VARIANCE OF THE ANATOMY AND FRACTURE PATTERN. THEREFORE, THE TRIAL HEAD WAS DESIGN TO BE LOOSE FIT ON THE TRIAL STEM TO MAKE IT EASY TO REMOVE AND QUICKLY REPLACE WITH A DIFFERENT SIZE TRIAL HEAD DURING THIS TIME OF THE OPERATION. BECAUSE OF THE SIDE-LOADING FEATURE AND LOOSE FIT DESIGN, IF THE SOFT TISSUE TENSION IS NOT CORRECT DUE TO HAVE A TOO SMALL TRIAL HEAD THAN REQUIRED, THE TRAIL HEAD WILL BE ABLE TO SLIDE AROUND ON TOP OF THE STEM IF THE FORCES ARE IN LINE WITH THE DOVETAIL FEATURE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS COMPLAINT WAS CONSIDERED INVALID.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(4).

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MARKET PREFERENCE EVALUATION (MPE) 4 DURING A RADIAL HEAD PROSTHESIS PROCEDURE, THE TRIAL HEAD WAS PUT IN PLACE AND IMAGES WERE TAKEN IN SEVERAL POSITIONS TO HELP DETERMINE CORRECT SIZE OF FINAL IMPLANT. IN THIS CASE, THE 22MM HEAD WAS INSERTED, BUT KEPT FALLING OFF WHILE TAKING IMAGES. 24MM TRIAL HEAD HAD NO PROBLEM. IT IS SUSPECTED THE 22MM KEPT FALLING OFF DUE TO LACK OF TENSION ON THE CONSTRUCT TO KEEP IT IN PLACE. THIS IS FROM RADIAL HEAD PROSTHESIS MPE 4. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185647 22MM TRIAL RADIAL HEAD 4MM HT EXTENSION/16.5MM KWI SYNTHES MONUMENT 6892956

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR