BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBALT HV BONE CEMENT 40GRAMS-JAPAN

    MDR report key: 5973293 · Received September 23, 2016

    Report

    Report Number
    0001825034-2016-03763
    Event Type
    Death
    Date Received
    September 23, 2016
    Date of Event
    August 17, 2016
    Report Date
    October 17, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LOD
    PMA / PMN Number
    PK051496
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). 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

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET U.S., BUT IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(46) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K051496.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CMK MOD 12/14 SZ202 L130 LOT#0001112237 ITEM#3553.202, STSTL FEM HD DIA28/ 0 MM 12/14 ITEM#P0201M28 LOT#00J3731063, E1 RINGLOC BIPOLAR 28 X 45 MM ITEM#110010454 LOT#144080, BIO PLUG 12.5 MM LOT#913680 ITEM#163010. 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: 0001825034-2017-08974, 0001825034-2017-08975.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPIRED DURING A BIPOLAR HIP HEMI-ARTHROPLASTY PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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
    624662 COBALT HV BONE CEMENT 40GRAMS-JAPAN BONE CEMENT LOD BIOMET ORTHOPEDICS N/A 944610

    Patients

    Seq Age Sex Outcome Treatment
    1 Death