BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPOLY 32MM RNGLC LNR HW SZ24

    MDR report key: 8018477 · Received October 30, 2018

    Report

    Report Number
    0001825034-2018-09989
    Event Type
    Injury
    Date Received
    October 30, 2018
    Date of Event
    July 29, 2018
    Report Date
    July 10, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K100048
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI#: (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. MEDICAL DEVICES: ITEM NUMBER: 12-115115, ITEM NAME: CER BIOLOXD MOD HD 32MM STD NK, LOT #: 2898668. ITEM NUMBER: 192111, ITEM NAME: ECHO POR FMRL LAT NC 11X135MM, LOT #: 977890. ITEM NUMBER: 16-116054, ITEM NAME: RNGLC+ LTD HOLE SHELL SZ54, LOT #: 517790. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 09990. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT HIP REVISION APPROXIMATELY 4 MONTHS POST-IMPLANTATION DUE TO RECURRENT DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858833 EPOLY 32MM RNGLC LNR HW SZ24 PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 489470

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R