BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS FEMORAL HEAD

    MDR report key: 6048276 · Received October 21, 2016

    Report

    Report Number
    0002648920-2016-03227
    Event Type
    Injury
    Date Received
    October 21, 2016
    Date of Event
    September 16, 2016
    Report Date
    December 12, 2017
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    PK953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 00875705201 SHELL WITH CLUSTER HOLES POROUS 52 MM O.D. SIZE II FOR USE WITH II LINERS LOT 61355467; 00784801401 MODULAR NECK X1 12/14 NECK TAPER USE WITH +0 HEADS ONLY LOT 60872472; 00771300600 MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS SIZE 6 LOT 61371875; 00875101036 LINER NEUTRAL 36 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL LOT 61349741. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED REVISION OP NOTES. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. REVIEW OF THE REVISION OP NOTES AND SURGEON FOLLOW UP NOTES, THE PATIENT SUFFERED FROM PAIN AND ELEVATED IONS. A SMALL PSEUDOTUMOR AROUND THE GREATER TROCHANTER AREA AND CORROSION WAS VISIBLE AT THE HEAD JUNCTION. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED 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.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT WAS REVISED FOLLOWING A HIP ARTHROPLASTY DUE TO PAIN, WEAR, CONAUSEA, ELEVATED COBALT AND CHROMIUM ION LEVELS, PSEUDOTUMOR, AND TRUNNIONS. DURING SURGERY, THERE WAS A SIGNIFICANT AMOUNT OF FLUID DISCHARGE FROM THE JOINT AND CORROSION BETWEEN THE HEAD AND NECK TRUNNION.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT WAS REVISED FOLLOWING A HIP ARTHROPLASTY DUE TO PAIN, NAUSEA, AND AN MRI WHICH REVEALED ELEVATED COBALT AND CHROMIUM ION LEVELS AND THE PRESENCE OF A PSEUDOTUMOR. DURING SURGERY, THERE WAS A SIGNIFICANT AMOUNT OF FLUID DISCHARGE FROM THE JOINT AND CORROSION BETWEEN THE HEAD AND NECK TRUNNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699769 VERSYS FEMORAL HEAD HIP PROSTHESIS JDI ZIMMER MANUFACTURING B.V. 61454985

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R