BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR MODULAR HEAD

    MDR report key: 10489839 · Received September 3, 2020

    Report

    Report Number
    0001825034-2020-03429
    Event Type
    Injury
    Date Received
    September 3, 2020
    Date of Event
    August 12, 2020
    Report Date
    October 30, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K032396
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 PROVIDED BY THE CUSTOMER. X-RAYS PROVIDED AND REVIEWED BY A THIRD PARTY HCP NOTES NO ABNORMALITY OF THE LEFT TOTAL HIP ARTHROPLASTY. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS 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). CONCOMITANT MEDICAL PRODUCTS: 13-104050 ¿ M/H RADIAL SHELL ¿ 180880, 51-106100 ¿ TAPERLOC STEM ¿ 2961666, EP-108323 ¿ E-POLY LINER ¿ 806660. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. 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 THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 7 YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. THE FEMORAL HEAD COMPONENT WAS REMOVED AND REPLACED WITH A LONGER IMPLANT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953454 COCR MODULAR HEAD PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 959230

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10