BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X42MM

    MDR report key: 9383125 · Received November 27, 2019

    Report

    Report Number
    0001825034-2019-05335
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    November 5, 2019
    Report Date
    March 3, 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

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-301322-ARCOS CON-474370, 11-301000- MOD FEMORAL PROX-810870, 010000663- G7 PPS LTD ACET SHELL- 6289244, 110024463- G7 DUAL MOBILITY LINER- 690310, 11-300815- ARCOS 15X150MM SPL TPR- 351720, 00625006535 BONE SCREW 6.5X35 SELF-TAP 63651675, 12-115110- CER BIOLOXD MOD- 2912205, 00223200418- CABLE CERCLAGE CABLE- 63989795. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 05336, 0001825034 - 2019 - 05337, 0001825034 - 2019 - 05338, 0001825034 - 2019 - 05339, 0001825034 - 2019 - 05341. 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 PATIENT UNDERWENT RIGHT HIP REVISION. SUBSEQUENTLY, PATIENT UNDERWENT THIRD REVISION APPROXIMATELY ONE AND HALF YEARS POST INITIAL IMPLANTATION FOR INFECTION. ALL DEVICES WERE REMOVED AND REPLACED WITH CEMENT SPACERS. SALES REP INDICATES NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181084 ACT ARTIC E1 HIP BRG 28X42MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. NI 017610 00880304485044

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R