BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E1 RINGLOC BIPOLAR 28X44MM

    MDR report key: 9483546 · Received December 17, 2019

    Report

    Report Number
    0001825034-2019-05585
    Event Type
    Malfunction
    Date Received
    December 17, 2019
    Date of Event
    November 15, 2019
    Report Date
    April 7, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K101086
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM 00877502802 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 28/0, TAPER 12/14 LOT#2993609, ITEM# UNKNOWN STEM LOT# UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING INITIAL HIP ARTHROPLASTY, THE HEAD DID NOT MOVE SMOOTHLY IN THE POLY LINER. THIS SURGERY WAS FINISHED WITH BACKUP PRODUCT. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276459 E1 RINGLOC BIPOLAR 28X44MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 454890

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10 NARRATIVE