BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC/X POR NC LAT 13X145

    MDR report key: 8186460 · Received December 20, 2018

    Report

    Report Number
    0001825034-2018-11497
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    March 23, 2017
    Report Date
    March 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K020580
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER:15-106056, ITEM NAME:M2A-38 CUP NON FLARED SZ 56MM, LOT #458980. ITEM NUMBER: 11-173665, ITEM NAME: M2A 38MM MOD HD+9MM NK NO SKRT, LOT #: 265890. REPORTED EVENT WAS CONFIRMED WITH MEDICAL RECORDS. RECORDS STATED CLEAR LOOSENING AND MIGRATION OF THA, ESPECIALLY THE ACETABULAR COMPONENT. ONCE IT BAND WAS OPENED, A LOT OF BROWN LIQUID FROM METALLOSIS REMOVED ACETABULAR COMPONENT AND REPLACED WITH STRYKER 62X56 DEEP PROFILE CUP WITH A SCREW THROUGH THE DOME AND TWO PERIPHERAL SCREWS. FEMORAL COMPONENT REPLACED, DEVICE AND SIZE NOT SPECIFIED NO OPERATIVE COMPLICATIONS NO DRAINS BLOOD LOSS LESS THAN 300 ML SPECIMENS SENT FOR CULTURE THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO RELATED DEVIATIONS/ ANOMALIES WERE IDENTIFIED THAT AFFECT THE REPORTED EVENT. 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 11-173665, ITEM NAME: M2A 38MM MOD HD+9MM NK NO SKRT, LOT #: 265890 ITEM NUMBER: X11-180313, ITEM NAME: BI-METRIC/X POR NC LAT 13X145, LOT #: 259990 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-09484, 0001825034-2018-09483. 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 PATIENT WAS REVISED APPROXIMATELY 13 YEARS POST-IMPLANTATION DUE TO PAIN, METALLOSIS, MIGRATION AND LOOSENING. A LARGE AMOUNT OF BROWN LIQUID FROM METALLOSIS WAS NOTED DURING SURGERY. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026495 BI-METRIC/X POR NC LAT 13X145 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 259990

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R