BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIA COBALT CHROME MODULAR HEAD +3MM NK

    MDR report key: 7453518 · Received April 24, 2018

    Report

    Report Number
    0001825034-2018-02398
    Event Type
    Injury
    Date Received
    April 24, 2018
    Date of Event
    April 3, 2018
    Report Date
    April 30, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM# 11-105904 ARCOM 28MM RINGLOC LINER HWALL 24 LOT# 802220, 135254 VISION RINGLOC SHELL 54MM SZ24 LOT# 318050, 103803 TPRLC REG POR FMRL 15.0X150 LOT# 550630. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2018 - 02396.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 1

    IT WAS REPORTED THAT PATIENT HAD INITIAL LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY 21 YEARS AGO. PATIENT RECENTLY EXPERIENCED DISLOCATION AND UNDERWENT REVISION SURGERY. ADDITIONAL INFORMATION REQUESTED AND RECEIVED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296040 28MM DIA COBALT CHROME MODULAR HEAD +3MM NK HIP PROSTHESIS JDI ZIMMER BIOMET, INC. N/A 553290

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R