BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPOLY 36MM RLC LNR MROM SZ24 ZE 24

    MDR report key: 11805184 · Received May 11, 2021

    Report

    Report Number
    0001825034-2021-01391
    Event Type
    Injury
    Date Received
    May 11, 2021
    Date of Event
    April 12, 2021
    Report Date
    August 4, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K070364
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO THE INFORMATION RECEIVED FROM THE CUSTOMER. X-RAY REVIEW STATES THAT THERE IS MILD RADIOLUCENCY ALONG THE PROXIMAL FEMUR SEEN WITH MILD OSTEOPENIA. NO FRACTURE SEEN. THE DEVICE HISTORY RECORD (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). CONCOMITANT MEDICAL DEVICES: 650-1057 CER BIOLOXD OPTION HD 36MM; 650-1063 258700 CER OPTION 12/14 TPR SLEEVE +7 /14; 650-1068 054980 CER OPTION TYPE 1 TPR SLEVE +6 PE 1; 103535 648900 TI LOW PROFILE SCREW 6.5X40MM; 16-116054 530890 RNGLC+ LTD HOLE SHELL SZ54; 123741 400270 3/8-24 APICAL HOLE PLUG 1/CUP. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE DEVICE WAS NOT RETURNED BY THE HOSPITAL. 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 INITIAL HIP ARTHROPLASTY ON UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASON. THE PATIENT WAS REVISED FOR A SECOND TIME APPROXIMATELY SIX YEARS LATER DUE TO PAIN AND DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700932 EPOLY 36MM RLC LNR MROM SZ24 ZE 24 PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 963830

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE