BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIHAPRO SHELL HA/PC 52MM LN 23

    MDR report key: 7360883 · Received March 22, 2018

    Report

    Report Number
    3002806535-2018-00564
    Event Type
    Injury
    Date Received
    March 22, 2018
    Date of Event
    April 28, 2015
    Report Date
    July 24, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL PRODUCT: DELTA CERAMIC FEM HD 028/ 0MM, CATALOG #: 164136, LOT #: 1673301. MEDICAL PRODUCT: BIHAPRO MK III HA/PC SZ6 LH T1, CATALOG #: 12-164566, LOT #: 1240273. MEDICAL PRODUCT: BIHAPRO FEM PMMA CNTRLZR 13MM, CATALOG #: 164204, LOT #: 1343577. MEDICAL PRODUCT: ARCOM 28MM RNGLOC LNR HWALL 23, CATALOG #: 11-105903, LOT #: 2009020675. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00617, 3002806535-2019- 00618, 3002806535-2019-00619, 3002806535-2019-00620. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. ROOT CAUSE 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 HAS BEEN REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT AN INITIAL HIP REPLACEMENT SURGERY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON DUE TO AVASCULAR HIP NECROSIS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENTS NOTICE AND THE ALLEGATIONS THERE IN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE 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. PLEASE NOTE, THIS EVENT HAS BEEN PREVIOUSLY REPORTED UNDER THE MEDWATCH FACILITY (B)(4). MFR REPORT NUMBER: 0009613350 - 2017 - 00540.

    Description of Event or Problem · 1

    THE PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A ZIMMER HIP MOM IMPLANT ON UNKNOWN SIDE ON UNKNOWN DATE. IT IS UNKNOWN IF THE PATIENT WAS REVISED OR IS BEING MONITORED DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204691 BIHAPRO SHELL HA/PC 52MM LN 23 HIP PROSTHESIS JDI BIOMET UK LTD. N/A 1170828

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R