BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL MOBILITY ACETABULAR LINER

    MDR report key: 6411543 · Received March 16, 2017

    Report

    Report Number
    0001825034-2017-01586
    Event Type
    Injury
    Date Received
    March 16, 2017
    Date of Event
    February 13, 2017
    Report Date
    February 9, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK150522
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: 110010271, G7 OSSEOTI MULTIHOLE 66MM, I R3714016A; EP-200160, ACT ARTIC E1 HIP BRG 28X54MM, 950150; UNKNOWN ZIMMER HEAD; UNKNOWN STEM. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS 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). MEDICAL PRODUCT ¿ BIOMET G7CUP CATALOG#: 110010271 LOT#: R3710416A, BIOMET BEARING CATALOG #: EP-200160 LOT# 950150. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 PATIENT WAS REVISED APPROXIMATELY ONE MONTH POST-IMPLANTATION DUE TO UNKNOWN REASONS. DURING THE PROCEDURE, AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED AND ACETABULAR CUP, LINER AND DUAL MOBILITY BEARING WERE REMOVED AND REPLACED. THERE WAS DIFFICULTY REMOVING THE METAL LINER, BUT IT DID NOT CAUSE A SIGNIFICANT DELAY OR PATIENT INJURY. NO OTHER PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193586 DUAL MOBILITY ACETABULAR LINER PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 879310

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R