BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGEN/RNGLC+ MULTI 66MM SZ 26

    MDR report key: 7067662 · Received November 29, 2017

    Report

    Report Number
    0001825034-2017-10514
    Event Type
    Injury
    Date Received
    November 29, 2017
    Date of Event
    October 29, 2015
    Report Date
    November 29, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK070369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: ARCOS TAPER STEM CAT# 22-300818 LOT#: 064020. MODULAR HEAD CAT#: 11-363662 LOT#: 080270. RINGLOC E-POLY LINER CAT#: EP-053660 LOT#: 3387738. ARCOS LATERAL TROCHANTERIC BOLT CAT#: 11-302132 LOT#: 963050. ARCOS TROCHANTERIC CLAW CAT# 11-302101 LOT#: 295220. ARCOS CONE CAT# 22-301302 LOT#: 244770. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES 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.

    Description of Event or Problem · 1

    IT WAS NOTED DURING AN X-RAY REVIEW THAT THERE IS RADIOLUCENCY AROUND THE ACETABULAR COMPONENT. THE PATIENT REPORTED PAIN. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847238 REGEN/RNGLC+ MULTI 66MM SZ 26 HIP, PROSTHESIS LPH ZIMMER BIOMET, INC. 903910

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention SEE H10