BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC/X POR NC 17X165

    MDR report key: 7335419 · Received March 13, 2018

    Report

    Report Number
    0001825034-2018-01815
    Event Type
    Injury
    Date Received
    March 13, 2018
    Date of Event
    October 18, 2017
    Report Date
    June 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MEH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 PATIENT UNDERWENT HIP REVISION APPROXIMATELY 12 YEARS POST-IMPLANTATION DUE TO PAIN, PSEUDOTUMOR, ELEVATED METAL ION, OSTEOLYSIS. DURING THE PROCEDURE, PSEUDOTUMOR, A LARGE AMOUNT OF OSTEOLYSIS, EXCESSIVE BLOOD LOSS AND YELLOW SYNOVIAL FLUID WAS NOTED. IT WAS ALSO NOTED THAT THE SURGERY REQUIRED ADDITIONAL TIME DUE TO THE PATIENT'S MORBID OBESITY.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT WILL NOT BE RETURNED DUE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: M2A 38MM MOD HD+9M, ITEM # 11-173665, LOT# 042190, MEDM2A 38MMX60MM CUP, ITEM # RD118860, LOT# 777390. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT: PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-01810; 0001825034-2018-01816.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION 12 YEARS POSTOPERATIVELY DUE TO UNKNOWN REASONS. ADDITIONAL INFORMATION REQUESTED AND ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177853 BI-METRIC/X POR NC 17X165 HIP PROSTHESIS MEH ZIMMER BIOMET, INC. N/A 689691

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R