BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER

    MDR report key: 6471976 · Received April 7, 2017

    Report

    Report Number
    0001822565-2017-01941
    Event Type
    Injury
    Date Received
    April 7, 2017
    Report Date
    January 3, 2018
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    PMA / PMN Number
    PK072121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS - TM REVISION SHELL 50MM/ PN 00-7000-050-20/ LN 62954261, BUTTRESS AUGMENT, SZ 54/ PN 00-4894-001-54/ LN 62940882, TRILOGY BONE SCREW 6.5X15/ PN 00-6250-065-15/ LN 63145238, TRILOGY BONE SCREW 6.5X20/ PN 00-6250-065-20/ LN 63044712, TRILOGY BONE SCREW 6.5X25/ PN 00-6250-065-25/ LN 63091985, TRILOGY BONE SCREW 6.5X25/ PN 00-6250-065-25/ LN 63103843, UNKNOWN HEAD/ PN AND LN'S UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2017-02160. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    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. A RADIOGRAPH WAS TAKEN, HOWEVER IT IS NOT ABLE TO BE REVIEWED AS THE DATE IT WAS TAKEN IS UNKNOWN. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT¿S HIP WAS REVISED DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255073 TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER HIP PROSTHESIS KWZ ZIMMER, INC. N/A 62550458

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R