BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC HD ARCOM XL 28X44MM

    MDR report key: 7148964 · Received December 27, 2017

    Report

    Report Number
    0001825034-2017-11199
    Event Type
    Injury
    Date Received
    December 27, 2017
    Report Date
    January 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK161190
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: G7 DUAL MOBILITY LINER 44MM F, CATALOG#: 110024464, LOT#: 994880; G7 OSSEOTI MULTIHOLE 54MM F, CATALOG#: 110010265, LOT#: 6039892; G7 SCREW 6.5MM X 20MM, CATALOG#: 010000997, LOT#: 6117918; G7 SCREW 6.5MM X 30MM, CATALOG#: 010000999, LOT#: 3801684; G7 SCREW 6.5MM X 20MM, CATALOG#: 010000997, LOT#: 6120435; G7 SCREW 6.5MM X 30MM, CATALOG#: 010000999, LOT#: 6115307; 28MM MOD HD STD NECK TP1 TAPER, CATALOG#: 163662, LOT#: 177940; MLRY-HD POR FMRL 9X150MM, CATALOG#: 11-104109, LOT#: 231220. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN LINER. 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: 0001825034-2017-11200.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DISLOCATED HER LEFT HIP IN POST-OPERATING ROOM DUE TO UNKNOWN REASON (SAME SIDE AS REVISION). ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927137 ACT ARTIC HD ARCOM XL 28X44MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 481530

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R