BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC/X POR COLLAR 14X150

    MDR report key: 8890992 · Received August 13, 2019

    Report

    Report Number
    0001825034-2019-03586
    Event Type
    Injury
    Date Received
    August 13, 2019
    Date of Event
    April 18, 2017
    Report Date
    October 17, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K020580
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MEDICAL RECORDS ESTIMATED BLOOD LOSS OF 300 CC. IRRIGATION AND DEBRIDEMENT OF LEFT THA; HEAD AND LINER EXCHANGED; PLACEMENT OF ANTIBIOTIC-IMPREGNATED BEADS. 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: 650-1055, CER BIOLOXD OPTION HD 28MM 027320, HEAD; 650-1067, CER OPTION TYPE 1 TPR SLEVE +3 617610, SLEEVE; EP-200156, ACT ARTIC E1 HIP BRG 28X50MM 274460, BEARING; US157856, M2A-MAGNUM PF CUP 56ODX50ID 914110, CUP. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-03588 CUP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A STAGE II RE-IMPLANTATION PROCEDURE FOR THE ONGOING INFECTION NINE YEARS POST INITIAL TOTAL HIP SURGERY. PATIENT HAS HAD MULTIPLE SURGERIES DUE TO INFECTION. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683739 BI-METRIC/X POR COLLAR 14X150 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 306760

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R