BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 10 DEG ARCOMXL LINER 36MM E

    MDR report key: 7974752 · Received October 17, 2018

    Report

    Report Number
    0001825034-2018-09796
    Event Type
    Injury
    Date Received
    October 17, 2018
    Date of Event
    October 11, 2018
    Report Date
    November 1, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 110010244 G7 OSSEOTI 3 HOLE SHELL 52MM E LOT# 6371433; ITEM# 12-115121 CER BIOLOXD MOD HD 36MM STD NK LOT# 2942338; ITEM# 192411 ECHO POR FMRL RED NC 11X135MM LOT# 411390. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY. SURGEON NOTED AFTER IMPLANTING THE LINER THAT IT WAS NOT SEATED CORRECTLY. WHILE DISLOCATING HIP TO RE-SEAT LINER, THE HEAD AND STEM WERE DAMAGED AND HAD TO BE REPLACED. ORIGINAL LINER/CUP USED TO COMPLETE SURGERY. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813849 G7 10 DEG ARCOMXL LINER 36MM E PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6155056

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R