BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC HIP SYSTEM ACETABULAR BI-POLAR CUP

    MDR report key: 6955946 · Received October 17, 2017

    Report

    Report Number
    0001825034-2017-08975
    Event Type
    Injury
    Date Received
    October 17, 2017
    Date of Event
    August 17, 2016
    Report Date
    October 17, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CMK MOD 12/14 SZ202 L130, LOT#0001112237, ITEM#3553.202, STSTL FEM HD DIA28/ 0MM 12/14, ITEM#P0201M28, LOT#00J3731063, BIO PLUG 12.5MM, LOT#913680, ITEM#163010, COBALT HV BN CMT 40G, (B)(4) LOT#944610, ITEM#402282J. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET US AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K051569. COMPLAINT WAS EVALUATED, AND THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTION WAS NOT PERFORMED. DEVICE HISTORY RECORD (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. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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: 0001825034-2016-03763, 0001825034-2017-08974.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED DURING A BIPOLAR HIP HEMI-ARTHROPLASTY PROCEDURE, AFTER THE PATIENT'S BLOOD PRESSURE DROPPED SUDDENLY. IT IS NOT BELIEVED THAT THE PRODUCTS CONTRIBUTED TO THE PATIENT'S DEATH, HOWEVER, CAUSE OF DEATH REMAINS UNKNOWN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735257 RINGLOC HIP SYSTEM ACETABULAR BI-POLAR CUP HIP PROSTHESIS LZO BIOMET ORTHOPEDICS N/A 144080

    Patients

    Seq Age Sex Outcome Treatment
    1 Death