BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR HEAD 32/ 0 'M' 12/14

    MDR report key: 8666047 · Received June 4, 2019

    Report

    Report Number
    0009613350-2019-00360
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    March 27, 2019
    Report Date
    December 20, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION CORRECTION: DATE OF REPORT, PREMARKET IDENTIFICATION, TYPE OF REPORT, ADDITIONAL MFR NARRATIVE. ADDITIONAL: ADVERSE EVENT PROBLEM. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: MEDICAL OTHER: BLOOD LOSS. EVENT SUMMARY: IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A PROCEDURE FOR A RIGHT THP IMPLANTATION ON (B)(6) 2009 AND REQUIRED 1 UNIT PRBC (PACKED RED BLOOD CELL) DURING PRIMARY. SURGERY COULD BE COMPLETED AND PRODUCTS WERE IMPLANTED SUCCESSFULLY. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS SURGICAL NOTES WERE RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. THE COMPATIBILITY CHECK WAS PERFORMED FROM (B)(6) AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. CONCLUSION SUMMARY: THE QUALITY RECORDS CHECK COULD NOT BE PERFORMED AS LOT NUMBERS ARE UNKNOWN. ANY TYPE OF BLOOD LOSS HAS THE POTENTIAL TO CAUSE A COMPLICATION. THE AMOUNT OF BLOOD LOSS THAT MAY LEAD TO INTRA AND/OR POSTOPERATIVE COMPLICATIONS DEPENDS ON THE INDIVIDUAL PERSON AND / OR COMORBIDITIES. PATIENT'S FULL MEDICAL HISTORY WAS NOT DISCLOSED; IT IS UNKNOWN WHETHER HE HAD A PREEXISTING A HEALTH CONDITION SUCH AS ANEMIA, HEMOPHILIA, ETC., OR IF HE WAS TAKING ANY MEDICATION WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DEVICE-RELATED COMPLICATION SUCH AS EXTENDED SURGICAL TIME DUE TO DIFFICULTY TO IMPLANT THE DEVICES WAS REPORTED. THEREFORE, BASED ON THE LIMITED AMOUNT OF INFORMATION, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2019-00357, 0009613350-2019-00360.

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM# 01.00551.307, LOT# UNKNOWN, FITMORE, HIP STEM, UNCEMENTED, OFFSET B (EXTENDED)/7, TAPER 12/14. ITEM# 14.32.06-20, LOT# UNKNOWN, COCR HEAD 32/ 0 'M' 12/14. PREMARKET IDENTIFICATION: THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K993259. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC., (B)(4) REFERENCE NUMBER (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2019-00357. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PRIMARY SURGERY THE PATIENT REQUIRED 1 UNIT OF PACKED RED BLOOD CELL (PRBC). ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460017 COCR HEAD 32/ 0 'M' 12/14 N/A JDI ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other