BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR HEAD TYPE 1 TAPER

    MDR report key: 7770486 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-08018
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    February 12, 2014
    Report Date
    October 16, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK032396
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: CATALOG #: 15-103205, TAPERLOC MICRO FEMORAL, LOT # 402250; CATALOG #: 11-104056, MALLORY HEAD SHELL WITH PLUG, LOT # 569300; CATALOG #: EP-105914, E-POLY RINGLOC ACETABULAR LINER, LOT # 974060. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-08017, 08018, 08019, 08020.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION AFTER INVESTIGATION, IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY TOTAL KNEE ARTHROPLASTY APPROXIMATELY 10 YEARS AGO. SUBSEQUENTLY, THE PATIENT HAD BILATERAL THA FOR HIV-ASSOCIATED AVN AND DEVELOPED CHRONIC BILATERAL TROCHANTERIC BURSITIS. THE PATIENT UNDERWENT LEFT GREATER TROCHANTERIC BURSECTOMY AND ILIOTIBIAL RELEASE APPROXIMATELY 4 YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609999 MODULAR HEAD TYPE 1 TAPER PROSTHESIS HIP JDI ZIMMER BIOMET, INC. N/A 505940

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other