BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ML TAPER STEM

    MDR report key: 6291304 · Received January 31, 2017

    Report

    Report Number
    0001822565-2017-00456
    Event Type
    Injury
    Date Received
    January 31, 2017
    Date of Event
    October 9, 2015
    Report Date
    April 27, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWA
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED OR CORRECTED. CONCOMITANT MEDICAL PRODUCTS - UNKNOWN 32MM FEMORAL HEAD, UNKNOWN TRILOGY ACETABULAR CUP, UNKNOWN TRILOGY ACETABULAR LINER, ALL CATALOG#'S: NI ALL LOT'S#: NI. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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 CONTRIBUTE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THIS ARTICLE WAS WRITTEN BY: NN. J. LASH,M. R. WHITEHOUSE, N. V. GREIDANUS, D. S. GARBUZ, B. A. MASRI, C. P. DUNCAN.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE RECEIVED THAT PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 62 MONTHS POST-IMPLANTATION DUE TO TWO DISLOCATIONS, PSEUDOTUMOR FORMATION, AND ADVERSE LOCAL TISSUE REACTION CAUSED BY TAPER CORROSION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON THE JOURNAL ARTICLE ENTITLED, DELAYED DISLOCATION FOLLOWING METAL-ON-POLYETHYLENE ARTHROPLASTY OF THE HIP DUE TO ¿SILENT¿ TRUNNION CORROSION. THE AIM OF THE ARTICLE WAS TO PRESENT A CASE SERIES OF TEN METAL-ON-POLYETHYLENE TOTAL HIP ARTHROPLASTIES (MOP THAS) WITH DELAYED DISLOCATION ASSOCIATED WITH UNRECOGNIZED ADVERSE LOCAL TISSUE REACTION DUE TO CORROSION AT THE TRUNNION AND PSEUDOTUMOUR FORMATION. IT WAS REPORTED THAT A PATIENT WAS REVISED 62 MONTHS POST-IMPLANTATION DUE TO DISLOCATION, PSEUDOTUMOR AND ADVERSE LOCAL TISSUE REACTION CAUSED BY TAPER CORROSION. NO FURTHER INFORMATION HAS BEEN PROVIDED AND PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74495 UNKNOWN ML TAPER STEM PROSTHESIS, HIP KWA ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R