BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZMR HIP SYSTEM KWZ

    MDR report key: 6415073 · Received March 17, 2017

    Report

    Report Number
    0001822565-2017-01715
    Event Type
    Malfunction
    Date Received
    March 17, 2017
    Date of Event
    February 14, 2017
    Report Date
    July 25, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK113296
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN CUP. UNKNOWN LINER. UNKNOWN HEAD. UNKNOWN STEM. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL AND PHOTOGRAPHIC INSPECTION OF THE DEVICE REVEALED A FRACTURE THROUGH THE HOLES IN THE CENTER OF THE DEVICE AND WEAR AND TEAR INDICATIVE OF EXTENSIVE USE DURING 14 YEARS OF FIELD LIFE. THERE ARE WARNINGS AND INSTRUCTIONS REGARDING PREVENTION OF THIS TYPE OF EVENT WITHIN THE PACKAGE INSERT AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE USE OF THE SLAP HAMMER ON THE WORN 14 YEAR OLD PROVISIONAL MAY HAVE CONTRIBUTED TO THE FAILURE OF THE DEVICE; HOWEVER, A CONCLUSIVE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CONE TRIAL WAS FRACTURED DURING REVISION SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196754 ZMR HIP SYSTEM KWZ PROSTHESIS, HIP LPH ZIMMER, INC. N/A 60017199

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR