BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM ACETABULAR SHELL WITH CLUSTER HOLES

    MDR report key: 7580447 · Received June 7, 2018

    Report

    Report Number
    0001822565-2018-03135
    Event Type
    Injury
    Date Received
    June 7, 2018
    Date of Event
    March 15, 2016
    Report Date
    August 21, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK091508
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES - ZIMMER M/L TAPER MODULAR FEMORAL STEM WITH KINECTIV TECHNOLOGY PRESS-FIT # ITEM 00771301100 LOT 63034215, SELF TAPPING BONE SCREW # ITEM 00625006525 LOT 63029103, NEUTRAL LINER # ITEM 00875101240 LOT 62995193, KINECTIVE TECHNOLOGY MODULAR NECK # ITEM 00784801400 LOT 62831447. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2016-02045, 0001822565-2018-03137, 0001822565-2018-03141 AND 0001822565-2018-03142. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. THE PRODUCT WAS NOT RETURNED THEREFORE, NO PRODUCT EVALUATION COULD BE CONDUCTED. THE DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND; HOWEVER, THE ROOT CAUSE WAS UNABLE TO 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 THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2016-02045-2 0001822565-2018-03137-1 0001822565-2018-03141-1 0001822565-2018-03142-1

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED 5 MONTHS POST INITIAL SURGERY DUE TO PAIN, LOSS OF FUNCTION AND LOOSENING OF THE FEMORAL COMPONENT. THE SURGEON REVISED ALL THE COMPONENTS WITH A CONCERN OF INFECTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421837 CONTINUUM ACETABULAR SHELL WITH CLUSTER HOLES PROSTHESIS HIP LPH ZIMMER BIOMET, INC. N/A 63042958

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R