BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD 0X36MM DIA

    MDR report key: 12210583 · Received July 22, 2021

    Report

    Report Number
    0001822565-2021-02033
    Event Type
    Injury
    Date Received
    July 22, 2021
    Date of Event
    September 24, 2020
    Report Date
    January 12, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED DUE TO THE REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AN INITIAL LEFT THA . THE PATIENT WAS THEN REVISED DUE TO PAIN. WITHIN THE JOINT CORROSION, TRUNNIONOSIS, AND A PSEUDOTUMOR WAS FOUND. THE HETEROTOPIC OSSIFICATION WAS EXCISED AND THE POLY SHOWED EVIDENCE OF OXIDATION. THE SHELL WAS WELL FIXED, AND THE LINER AND HEAD WERE REPLACED WITH ZIMMER PRODUCTS WITHOUT COMPLICATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 6 YEARS POST IMPLANTATION DUE TO PAIN, CREVICE CORROSION, TRUNNIONOSIS, METALLOSIS, AND PSEUDOTUMOR FORMATION. DURING THE REVISION, HETEROTOPIC OSSIFICATION AND NECROTIC TISSUE WAS DEBRIDED. THE HEAD AND LINER WERE EXCHANGED WITHOUT COMPLICATION. NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    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 PRODUCTS: 00-7711-015-20, ML TAPER SZ15.0 EXT OFFSET; 00-6200-062-22, F/M ACET SHELL 62MMOD CLUSTER; 00-6310-062-36, XLPE 10 DEG POLY LINER 62X36; 00-6250-065-25, TRILOGY BONE SCR 6.5X25; 00-6250-065-30, TRILOGY BONE SCR 6.5X30; 00-7711-015-20, ML TAPER SZ15.0 EXT OFFSET; 98-0001-000-11. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 6 YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107568 FEMORAL HEAD 0X36MM DIA PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 62561477

    Patients

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