BEUDAMED
    FDA Adverse Event Death Summary report: N

    CEMENT WITH GENTAMYCINE

    MDR report key: 11730385 · Received April 27, 2021

    Report

    Report Number
    3006946279-2021-00073
    Event Type
    Death
    Date Received
    April 27, 2021
    Date of Event
    August 14, 2020
    Report Date
    September 10, 2021
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A COMBINATION PRODUCT (B)(4) THE PRODUCT ANALYSIS CAN'T BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE BRAND, REFERENCE OR BATCH WERE NOT COMMUNICATED. 7 OTHERS COMPLAINT ON PATIENT DEATH WAS RECORDED ON CEMENT PACK AND OPTIPAC, FROM (B)(6)2018 TO (B)(6)2021. ACCORDING TO AVAILABLE DATA, ROOT CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO WAS PART OF POLAR-TOTAL KNEE ARTHROPLASTY CLINICAL STUDY HAS DIED. THE CAUSE OF DEATH IS DUE TO MASSIVE BRAIN HEMORRHAGE. THE EXACT DATE OF PATIENT DEATH IS NOT KNOWN.

    Additional Manufacturer Narrative · 1

    THIS IS A COMBINATION PRODUCT. (B)(4). REPORT SOURCE, FOREIGN AND STUDY - EVENT OCCURRED IN (B)(6). LIST OF ASSOCIATED PRODUCTS : PS FEMORAL POROUS, STANDARD, SIZE 9, RIGHT; REF : 42500806602 BATCH : 63111358; PERSONA TIBIAL BASE PLATE (RIGHT) SIZE F; REF : 42532007502 BATCH : 63198951; PERSONA PS CONV (RIGHT) SIZE 7, 10MM + THICK; REF : 42521400710 BATCH : 63470553; PERSONA ALL POLY 35MM PATELLA; REF : 42540000035 BATCH : 63426281. THE DEVICE MANUFACTURING QUALITY RECORD CAN'T BE DONE SINCE THE BATCH WASN'T COMMUNICATED. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. REFERENCE - BATCH NUMBER WASN'T SHARED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO WAS PART OF POLAR-TOTAL KNEE ARTHROPLASTY CLINICAL STUDY HAS DIED. THE CAUSE OF DEATH IS DUE TO MASSIVE BRAIN HEMORRHAGE. THE EXACT DAT OF PATIENT DEATH IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628009 CEMENT WITH GENTAMYCINE BONE CEMENT, ANTIBIOTICS MBB BIOMET FRANCE S.A.R.L. NOT COMMUNICATED

    Patients

    Seq Age Sex Outcome Treatment
    1 Death SEE THE ASSOCIATED PRODUCTS IN H10.