BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM 28MM RNGLOC LINER HWALL 23

    MDR report key: 6865578 · Received September 14, 2017

    Report

    Report Number
    0001825034-2017-07074
    Event Type
    Injury
    Date Received
    September 14, 2017
    Date of Event
    August 17, 2017
    Report Date
    October 19, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK023357
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. CONCOMITANT PRODUCT(S): A 11-106050, R/B RLOC LHOLE SHL 50MM SZ 23, 302180. A 11-163662, 28MM M2A MOD HEAD STD NK, 096300. A 103533, TI LOW PROFILE SCREW 6.5X30MM, 658860. A 163662, 28MM MOD HD STD NECK TP1 TAPER, 096300. 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

    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 RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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 · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION PROCEDURE FIFTEEN YEARS POST-IMPLANTATION DUE TO WEAR. THE ACETABULAR CUP, LINER, AND HEAD WERE REVISED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645631 ARCOM 28MM RNGLOC LINER HWALL 23 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 098760

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R