BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 19X150MM SPL TPR DIST

    MDR report key: 8044338 · Received November 6, 2018

    Report

    Report Number
    0001825034-2018-10169
    Event Type
    Injury
    Date Received
    November 6, 2018
    Date of Event
    October 12, 2018
    Report Date
    January 31, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI : (B)(4). CONCOMITANT MEDICAL PRODUCTS : ITEM# 11-301305 ARCOS CON SZ E STD 60MM LOT# 879210, ITEM# 110010271 G7 OSSEOTI MULTIHOLE 66MM I LOT# 6002518, ITEM# 010000998 G7 SCREW 6.5MM X 25MM LOT# 6135022, ITEM# 010000998 G7 SCREW 6.5MM X 25MM LOT# 6196305, ITEM# EP-200160 ACT ARTIC E1 HIP BRG 28X54MM LOT# 211710, ITEM# 110024467 G7 DUAL MOBILITY LINER 54MM LOT# 432790, ITEM# 650-1158 DELTA CER FEM HD 28/0MM T1 LOT# 2017020166. REPORTED EVENT WAS CONFIRMED BY REVIEW OF XRAYS WHICH INDICATED PATIENT EXPEREINCED AN OBLIQUE FRACTURE INVOLVING THE PROXIMAL TO MID RIGHT FEMORAL DIAPHYSIS JUST DISTAL TO THE TIP OF THE HARDWARE EXTENDING INTO THE ANTERIOR CORTEX. NO SIGNS OF LOOSENING, WEAR, AND RADIOLUCENCY. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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). FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE LOCATION OF THE DEVICE IS UNKNOWN. 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 PATIENT¿S HIP WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880692 ARCOS 19X150MM SPL TPR DIST PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 585790

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNKNOWN CUP| UNKNOWN HEAD| UNKNOWN LINER