BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRAL/X POR RED PROX 10MM

    MDR report key: 8800987 · Received July 17, 2019

    Report

    Report Number
    0001825034-2019-03071
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    February 27, 2018
    Report Date
    September 23, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K042029
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF OP NOTES WHICH INDICATED THE TRUNNION WAS COLD WELDED ON AND THEREFORE HAD TO USE A CUTTING BURR TO REMOVE. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PART: 157444, M2A-MAGNUM MOD HD SZ 44MM, LOT: 189150; PART: 139256, M2A-MAGNUM 42-50 TPR INSRT STD, LOT: 872110; PART: US157850, M2A-MAGNUM PF CUP 50ODX44ID, LOT: 330620; PART: X12-171310, INTEGRAL/X POR RED PROX 10MM, LOT: 087460. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: NECK: 0001825034-2019-03069.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD INITIAL LEFT TOTAL HIP ARTHROPLASTY PERFORMED. DURING THE REVISION PROCEDURE, THE HEAD WAS FOUND TO BE COLD WELDED ON THE TRUNNION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592733 INTEGRAL/X POR RED PROX 10MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 087460

    Patients

    Seq Age Sex Outcome Treatment
    1