BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER LINER

    MDR report key: 6215753 · Received December 30, 2016

    Report

    Report Number
    0001822565-2016-04750
    Event Type
    Injury
    Date Received
    December 30, 2016
    Report Date
    July 19, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED, AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTRIBUTE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE MAY BE NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THE EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001822565-2016-04748, 0001822565-2016-04750, 0001822565-2017-04004.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED THROUGH THIRD-PARTY REVIEW OF RADIOGRAPHS, REVIEW OF THE X-RAY NOTED "COMMINUTED FRACTURE OF THE PROXIMAL FEMUR, FRACTURE OF THE METAL ACETABULAR CUP, AND POSSIBLE BONE FRACTURE SUPERIOR LATERAL ACETABULAR RIM.¿ THE PATIENTS BONE CONDITION WAS NOTED AS GENERALLY OSTEOPENIC WHICH MAY HAVE CONTRIBUTED TO PROXIMAL FEMUR FRACTURE EVENT. IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THE EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001822565-2016-04748, 0001822565-2016-04750, 0001822565-2017-04004.

    Description of Event or Problem · 1

    A HIP REVISION PROCEDURE HAS BEEN INDICATED DUE TO STEM LOOSENING AND POLY WEAR; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, ADDITIONAL INFORMATION IS UNAVAILABLE.

    Description of Event or Problem · 1

    A HIP REVISION PROCEDURE HAS BEEN INDICATED DUE TO STEM LOOSENING AND POLY; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. IT WAS REPORTED THE PATIENT DOES NOT WANT TO BE REVISED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED POSSIBLE LOOSENING OF THE STEM, POLY WEAR AND A HIP FRACTURE. HOWEVER, NO REVISION PROCEDURE WAS PERFORMED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865761 UNKNOWN ZIMMER LINER HIP PROSTHESIS KWZ ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other