BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM MODULAR HEAD TYPE 1 TAPER STANDARD

    MDR report key: 6407796 · Received March 15, 2017

    Report

    Report Number
    0001825034-2017-01619
    Event Type
    Injury
    Date Received
    March 15, 2017
    Date of Event
    November 4, 2016
    Report Date
    June 9, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK032396
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MALLORY/HEAD FEMORAL STEM, CATALOG#: 11-104212, LOT#: 213430; RINGLOC ACETABULAR LINER, CATALOG#: EP-105995, LOT#: 404750; RINGLOC ACETABULAR CUP, CATALOG#: PT-106060, LOT#: 376870; LOW PROFILE SCREW, CATALOG#: 103535, LOT#: 380580 AND 642070; LOW PROFILE SCREW, CATALOG#: 103532, LOT#: 420480. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THIS REPORT IS NUMBER 2 OF 4 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2017-01618, 01619, 01621, 01639).

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED SO NO PRODUCT EVALUATION COULD BE CONDUCTED. THIS DEVICE WAS USED FOR TREATMENT. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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 · 1

    IT WAS REPORTED IN MEDICAL NOTES RECEIVED THAT PATIENT UNDERWENT A PROCEDURE APPROXIMATELY 12 MONTHS POST-IMPLANTATION DUE TO PAIN. THE PATIENT HAD A TEMPORARY STIMULATOR IMPLANTED, AND ONE MONTH LATER RECEIVED A PERMANENT STIMULATOR. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189915 36MM MODULAR HEAD TYPE 1 TAPER STANDARD PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 049900

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R