BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X42MM

    MDR report key: 9375544 · Received November 26, 2019

    Report

    Report Number
    0001825034-2019-05333
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    July 29, 2018
    Report Date
    February 10, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304485044
    PMA / PMN Number
    K101336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    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. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 12-115110- CER BIOLOXD MOD- 2895349, 11-301322- ARCOS CON SZ B STD-UNKNOWN, 11-301000-FEMORAL PROX LOCKING SCREW- 810870, 00223200418- CABLE CERCLAGE- 63989795, 010000663- G7 PPS LTD ACET SHELL- 6289244, 00625006535- BONE SCR 6.5X35 SELF-TAP- 63651675, 110024463- G7 DUAL MOBILITY LINER- 690310. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, REQUESTED BUT NOT RETURNED BY HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REQUESTED BUT NOT RETURNED BY HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT HIP REVISION. SUBSEQUENTLY, PATIENT UNDERWENT REVISION DUE TO INFECTION LESS THAN ONE YEAR POST-OPERATIVE. PATIENT WAS WASHED OUT AND THE HEAD AND BEARING COMPONENTS WERE REMOVED AND REPLACE. SALES REP INDICATES NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170347 ACT ARTIC E1 HIP BRG 28X42MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. NI 006190 00880304485044

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R