BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL HIP SYSTEM

    MDR report key: 5347372 · Received January 6, 2016

    Report

    Report Number
    MW5058903
    Event Type
    Injury
    Date Received
    January 6, 2016
    Date of Event
    April 15, 2015
    Report Date
    December 10, 2015
    Manufacturer
    BIOMEDTRIX, LLC
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY DOG RECEIVED A HIP REPLACEMENT DURING (B)(6) 2015, MANUFACTURED FOR BIOMEDTRIX LLC., COMPANY ((B)(4)) AND DURING THE FIRST PROCEDURE, THE DOCTOR (DR. (B)(6)) DISCOVERED HE HAD RECEIVED A "MIX PRODUCT" (MISBRANDED AND ADULTERATED MEDICAL DEVICE) AND HE HAD TO CLOSE THE WOUND (HAD ALREADY CUT BONES). THE NEXT DAY, THE DR HAD TO RE-OPEN THE WOUND AND FINISH THE (2ND) SURGERY. THE FIRST SURGERY FOR THE HIP REPLACEMENT WAS PERFORMED WITH A SCREW ATTACHMENT SYSTEM. AFTER 6 WEEKS, THE DOG DISLOCATED THE HIP WHICH THE DOCTOR INDICATED WAS NOT COMMON AND THEN HAD TO GO BACK AND PERFORM ANOTHER (3RD) SURGERY WITH ANOTHER TYPE OF HIP CUP WHICH HAD TO BE CEMENTED TO THE HIP. AFTER SEVERAL DAYS, THE DOG HAD A CHRONIC ALLERGIC REACTION AND HAD TO BE HOSPITALIZED FOR RECUPERATION. AFTER 6 MONTHS, THE DOG HAS NOT RECUPERATED. THE DOG IS LIMPING, IN-PAIN, CAN'T SIT DOWN, DOES NOT EAT NORMALLY DUE TO THE PAIN AND TAKES MEDICATION FOR THE PAIN. I HAD CONTACTED THE MFR DURING THE PAST 8 MONTHS WITHOUT OBTAINING ANY REASONABLE RESPONSE REGARDING MY COMPLAINT. I HAD REVIEWED THE FDA SITE AND PER THEIR DEFINITION THE AGENCY HAD REGULATORY OVERSIGHT OF A MISBRANDED AND ADULTERATED MEDICAL DEVICE USED FOR HUMANS AND/OR ANIMALS, WHICH APPLIES DUE TO NONCONFORMING PRODUCT WAS DUE TO MIXED PRODUCT. THE HIP REPLACEMENT SYSTEM BOX INDICATES THAT THE PRODUCT IS MANUFACTURED FOR BIOMEDTRIX. HOWEVER, THE PRODUCT IS SUPPOSEDLY MANUFACTURED IN (B)(4), WHICH IS NOT INDICATED ON THE PACKAGE AND NO CE MARK IS INDICATED. THE MFR (BIOMEDTRIX, LLC.) INDICATED THAT THEY HAD TO INITIATE A NATIONAL RECALL REGARDING THE "MIX PRODUCT" (MISBRANDED AND ADULTERATED MEDICAL DEVICE) LOT INCIDENT. BIOMEDTRIX, LLC, NEVER COMMUNICATED THE ASSIGNMENT OF A MFR COMPLIANT NUMBER TO ME. (B)(4) BIOMEDTRIX, LLC., HAD INDICATED TO ME BY PHONE COMMUNICATION THAT PRODUCTS HAD TO BE RECALLED WITHIN THE UNITED STATES AND HAD INDICATED THAT ANOTHER INCIDENT HAD BEEN REPORTED FROM (B)(6). (B)(4) BIOMEDTRIX, LLC., HAD INDICATED TO ME BY PHONE COMMUNICATION THAT THEY WERE NOT REGULATED BY FDA AND/OR ANY (B)(6) GOVERNMENTAL AGENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8768 UNIVERSAL HIP SYSTEM CANINE TOTAL HIP REPLACEMENT (THR) LPH BIOMEDTRIX, LLC 762713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S