BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ A STD 50MM

    MDR report key: 8086715 · Received November 19, 2018

    Report

    Report Number
    0001825034-2018-10675
    Event Type
    Injury
    Date Received
    November 19, 2018
    Date of Event
    October 23, 2018
    Report Date
    August 2, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT OF DISLOCATION WAS CONFIRMED BY REVIEW OF XRAYS WHICH INDICATED SUPERIOR DISLOCATION OF THE PROSTHETIC FEMORAL HEAD FROM THE ACETABULAR CUP. NO FRACTURE. VISUAL INSPECTION OF THE CONE BODY IDENTIFIED DAMAGES NEAR THE CONE BODY NECK. VISUAL INSPECTION OF THE DISTAL STEM IDENTIFIED SCRATCHES AND SCUFFINGS ON THE TAPER SECTION. VISUAL INSPECTION OF THE SCREW IDENTIFIED NO VISIBLE DAMAGES. WEAR MARKS WERE VISIBLE ON THE TAPER OF THE CONE BODY. THE STEM AND CONE BODY WAS ASSEMBLED AND LOCKED WITH THE SCREW AND THERE WAS NO MOVEMENT OR LOOSENING FOUND. BIOMET STEM IS USED IN CONJUNCTION WITH ZIMMER'S HEAD AND ZIMMER-BIOMET HAS NOT ASSESSED OR CONFIRMED THE COMPATIBILITY OF THESE COMBINATIONS OF DEVICES. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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). MEDICAL DEVICES: ITEM# 11-300812 ARCOS 12X150MM SPL TPR DIST LOT# 781840; ITEM# UNKNOWN ,UNKNOWN SCREW LOT# UNKNOWN; ITEM# 00877503202 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14 LOT# 2857160; ITEM# 00875704801 SHELL WITH CLUSTER HOLES POROUS 48 MM O.D. SIZE GG FOR USE WITH GG LINERS LOT# 63475757; ITEM# 00885100832 NEUTRAL LINER 32 MM I.D. SIZE GG FOR USE WITH 48 MM O.D. SIZE GG SHELL LOT# 63475757. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 - 2018 - 10677; 0001825034 - 2018 - 10676.

    Description of Event or Problem · 1

    PATIENT UNDERWENT REVISION 2 YEARS POST IMPLANTATION DUE TO DISLOCATION BETWEEN THE BODY AND THE DISTAL STEM LOOSENING RESULTING IN DISLOCATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924840 ARCOS CON SZ A STD 50MM PROSTHESIS HIP KWA ZIMMER BIOMET, INC. N/A 950060

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R