BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CERAMIC HEAD

    MDR report key: 17133566 · Received June 15, 2023

    Report

    Report Number
    3002806535-2023-00191
    Event Type
    Injury
    Date Received
    June 15, 2023
    Date of Event
    June 22, 2020
    Report Date
    June 15, 2023
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ASSOCIATED PRODUCTS: ITEM NUMBER: 193109, ITEM NAME: ECHO B-MTRC MP FP HO 9 , ITEM LOT: 089870. ITEM NUMBER: 110010243, ITEM NAME:G7 OSSEOTI 3 HOLE SHELL 50MM D, ITEM LOT: 6378467. ITEM NUMBER: 010000856, ITEM NAME:G7 NEUTRAL E1 LINER 36MM D, ITEM LOT: 6383738. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF MANUFACTURING RECORDS CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. PATIENT PRESENTED WITH GREATER TROCHANTERIC BURSITIS OF THE LEFT HIP WAS PROSCRIBED STRETCHING EXERCISES, CONTRIBUTING FACTORS OF EVENT: RECURRENT FALLS DUE TO ALCOHOLISM AND RECENT TREATMENT FOR CELLULITIS/SUPERFICIAL INFECTION OF THE BUTTOCK WHICH CAN INCREASE THE INFLAMMATION IN THE JOINT. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT 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. H3 OTHER TEXT : PRODUCT AND PRODUCT DATA NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP TOTAL ARTHROPLASTY. APPROXIMATELY A YEAR AND A HALF AFTER INITIAL SURGERY, HAS BEEN DIAGNOSED WITH BURSITIS AND TREATED WITH FORMAL PHYSICAL THERAPY AND OVER THE COUNTER TOPICAL CREAM FOR ONGOING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230528 UNKNOWN CERAMIC HEAD HIP PROSTHESIS LZO BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H