BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHELL POROUS WITH CLUSTER HOLES

    MDR report key: 8755031 · Received July 2, 2019

    Report

    Report Number
    0002648920-2019-00491
    Event Type
    Injury
    Date Received
    July 2, 2019
    Report Date
    October 30, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    K934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    003

    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 RECEIVED FROM THE CUSTOMER. NO MEDICAL RECORDS REGARDING THE REVISION WERE RECEIVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #00771101300 FEMORAL STEM LOT #60968916, ITEM #00631005632 LINER LOT #61300290, ITEM #00801803202 FEMORAL HEAD LOT #61338132. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCTS REMAIN IMPLANTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920 -2019 -00490, 0001822565 -2019 -02044-1, 0001822565 -2019 -02045-1.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT IS BEING CONSIDERED FOR A REVISION APPROXIMATELY 10 YEARS POST INITIAL IMPLANTATION FOR UNKNOWN REASON. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550035 SHELL POROUS WITH CLUSTER HOLES HIP PROSTHESIS LPH ZIMMER MANUFACTURING B.V. N/A 61316056

    Patients

    Seq Age Sex Outcome Treatment
    1 Other