BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK CUP

    MDR report key: 9519865 · Received December 26, 2019

    Report

    Report Number
    0001825034-2019-05751
    Event Type
    Malfunction
    Date Received
    December 26, 2019
    Date of Event
    December 6, 2019
    Report Date
    March 2, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE CUP WAS DETERMINED TO BE NOT REPORTABLE AND DID NOT CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE CUP WAS DETERMINED TO BE NOT REPORTABLE AND DID NOT CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET LINER, CAT#010000945, LOT#200522. BIOMET LINER, CAT#010000828, LOT#6346634. UNK CUP, UNK HEAD, UNK STEM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO LOCATION OF DEVICE IS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-05749, 0001825034-2019-05750, 0001825034-2019-05751.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LINERS WOULD NOT ENGAGE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316893 UNK CUP PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1