BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REJUVENATE/ABGII MODULAR STEM

    MDR report key: 3002359 · Received March 13, 2013

    Report

    Report Number
    0002249697-2013-00961
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    January 1, 2009
    Report Date
    June 19, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    Removal / Correction Number
    Z-2089-2012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN HIP.THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO THE ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4): NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A PATIENT WHO WAS WARNED BY THEIR PHYSICIAN ABOUT THEIR COBALT AND CHROMIUM LEVELS INVOLVING AN UNKNOWN METAL-ON-METAL HIP WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR IDENTIFICATION OR EVALUATION. A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THE DEVICE WAS NOT PROPERLY IDENTIFIED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THROUGH THE FILING OF A LAWSUIT THAT IN (B)(6) 2009 THE PATIENT UNDERWENT HIP REPLACEMENT SURGERY AT (B)(6) HOSPITAL, DURING WHICH HE RECEIVED A STRYKER METAL ON METAL HIP REPLACEMENT DEVICE. IT IS ALLEGED THAT ON (B)(6) 2012, HIS PHYSICIAN WARNED HIM OF HIS COBALT AND CHROMIUM LEVELS. HE FURTHER ALLEGES THAT ... "THE DEVICES HAVE DEMONSTRATED EXCESSIVE FAILURE RATES AND ARE PRONE TO PREMATURE FAILURE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THROUGH THE FILING OF A LAWSUIT THAT IN (B)(6) 2009 THE PATIENT UNDERWENT HIP REPLACEMENT SURGERY AT (B)(6) HOSPITAL, DURING WHICH HE RECEIVED A STRYKER METAL ON METAL HIP REPLACEMENT DEVICE. IT IS ALLEGED THAT ON (B)(6), 2012 HIS PHYSICIAN WARNED HIM OF HIS COBALT AND CHROMIUM LEVELS. HE FURTHER ALLEGES THAT ... "THE DEVICES HAVE DEMONSTRATED EXCESSIVE FAILURE RATES AND ARE PRONE TO PREMATURE FAILURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104993 UNKNOWN REJUVENATE/ABGII MODULAR STEM HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES MBH STRYKER ORTHOPAEDICS-MAHWAH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other