BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A ACETABULAR CUP

    MDR report key: 7335416 · Received March 13, 2018

    Report

    Report Number
    0001825034-2018-01810
    Event Type
    Injury
    Date Received
    March 13, 2018
    Date of Event
    October 18, 2017
    Report Date
    August 22, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED DUE TO REVIEW OF PROVIDED MEDICAL RECORDS. DHR WAS REVIEWED AND NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT WILL NOT BE RETURNED FOR INVESTIGATION DUE TO LOCATION IS UNKNOWN. ONCE INVESTIGATION IS COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT: M2A 38 MM MOD HD-ITEM#11-173665 LOT# 042190; BI METRIC/X POR NC ITEM# X180317 LOT # 689691. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT: PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-01815; 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.

    Additional Manufacturer Narrative · 1

    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 · 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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177850 M2A ACETABULAR CUP PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 777390

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R