BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIPOLAR BIPOLAR CUP

    MDR report key: 6177388 · Received December 15, 2016

    Report

    Report Number
    0002648920-2016-04379
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 14, 2016
    Report Date
    February 14, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    KWY
    PMA / PMN Number
    PK833991
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 00500104222 LINER 22 MM I.D. FOR USE WITH 42/43 MM O.D. SHELLS 62920232. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR 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 WERE TRENDS 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE C-RING WAS MISALIGNED AND WOULD NOT ALLOW THE LINER TO SEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828352 MULTIPOLAR BIPOLAR CUP PROSTHESIS, HIP KWY ZIMMER MANUFACTURING B.V. N/A 62624601

    Patients

    Seq Age Sex Outcome Treatment
    1