BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR FEMORAL STEM

    MDR report key: 10053397 · Received May 13, 2020

    Report

    Report Number
    0001822565-2020-01711
    Event Type
    Injury
    Date Received
    May 13, 2020
    Report Date
    May 13, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K063251
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00801804002 61112139 FEMORAL HEAD STERILE, 00784802301 60816128 MODULAR NECK, EP-108524 980580 E-POLY 40MM +3 HIWALL LNR SZ24, 106054 791840 RAN/BUR RNGLC SHL 54MM SZ 24, 103530 874060 TI LOW PROFILE SCREW 6.5X15MM, 103532 859980 TI LOW PROFILE SCREW 6.5X25MM. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE PATIENT UNDERWENT INITIAL LEFT THA SURGERY DUE TO ARTHRITIS OF THE LEFT HIP WITH LEG LENGTH INEQUALITY; THERE WERE NO INTRAOPERATIVE COMPLICATION NOTED. THERE IS NO RECORD OF A REVISION SURGERY AND NO ISSUES REPORTED WITH THE IMPLANTED DEVICES. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2020-00137 AND 0001822565-2020-00139.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENTS LEGAL COUNSEL THAT THE PATIENT HAD A LEFT HIP ARTHROPLASTY APPROXIMATELY TEN YEARS AGO. PLAINTIFF HAS NOT YET SCHEDULED A SURGERY FOR EXPLANATION OF THE LEFT HIP COMPONENTS AT ISSUE. PATIENT ISSUES ARE UNKNOWN. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516698 MODULAR FEMORAL STEM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 60910203

    Patients

    Seq Age Sex Outcome Treatment
    1 Other