BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERIC CERAMIC HEAD

    MDR report key: 7761261 · Received August 8, 2018

    Report

    Report Number
    0009613350-2018-00713
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    January 2, 2018
    Report Date
    April 11, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. PRODUCT STICKERS INDICATE THAT THE DEVICES IMPLANTED IN JANUARY 2ND ARE NOT ZIMMER BIOMET. PLEASE VOID THE REPORTS 0009613350-2018-00713 -1. ZIMMER GMBH CONSIDERS THIS CASE AS NOT A COMPLAINT. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORDS (DHR): THE DHR CHECK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. NO TREND ANALYSIS COULD BE PERFORMED AS NO ITEM NUMBER(S) IS/ARE AVAILABLE. EVENT SUMMARY: A LEGAL DOCUMENT FOR SPLIT CASE (B)(4) FROM ZIMMER INC., WARSAW WAS RECEIVED AND STATED THE FOLLOWING: FURTHER, DR. (B)(6) USED A CERAMIC HEAD TO AVOID FURTHER METAL CORROSION ISSUES AT THE NECK TAPER. FOLLOWING HER REVISION SURGERY, SUFFERED AND CONTINUES TO SUFFER FROM AN ONGOING INFECTION REQUIRING PLACEMENT OF AN ANTIBIOTIC SPACER. ACCORDINGLY, THE CASE AT HAND TREATS THE INFECTION AFTER IMPLANTATION OF A CERAMIC HEAD. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS; ACCORDING TO THE INFORMATION RECEIVED THAT THE DEVICE IS STILL IN VIVO. ROOT CAUSE ANALYSIS: NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES WERE RECEIVED; THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AS IT IS STILL IN VIVO, THEREFORE THE CONDITION OF THE COMPONENT IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY IS UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. HOWEVER, ALL POSSIBLE CAUSES RELATED TO THE ISSUES REPORTED ARE LISTED IN THE DFMEA WHICH IS AVAILABLE FOR EVERY ZIMMER IMPLANT AND IS CONTINUOUSLY MONITORED AND UPDATED. POSSIBLE CAUSES OF INFECTION INCLUDE WRONG HANDLING OF DEVICE DUE TO WRONG INFORMATION, WRONG RESTERILIZATION PROCEDURES FOR STERILE DELIVERED PARTS OR PACKAGING FAILURE DURING TRANSPORTATION. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. THEREFORE, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. CONCLUSION SUMMARY: NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANT(S) WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT(S) IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. POSSIBLE CAUSES OF INFECTION INCLUDE WRONG HANDLING OF DEVICE DUE TO WRONG INFORMATION, WRONG RESTERILIZATION PROCEDURES FOR STERILE DELIVERED PARTS OR PACKAGING FAILURE DURING TRANSPORTATION. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. THEREFORE, AN EXACT ROOT CAUSE CANNOT 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).

    Description of Event or Problem · 0

    PRODUCT STICKERS INDICATE THAT THE DEVICES IMPLANTED IN JANUARY 2ND ARE NOT ZIMMER BIOMET. PLEASE VOID THE REPORTS 0009613350-2018-00713 -1.

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    DUE TO FACT THAT THIS IS A LEGAL CLAIM, OUR LEGAL DEPARTMENT HAS BEEN PROVIDED WITH THE AVAILABLE FACTS FROM THE CUSTOMER. ZIMMER (B)(4) LEGAL DEPARTMENT IS WELL TRAINED AND PASSES ALL INFORMATION CONCERNING THE CASE TO OUR COMPLAINT HANDLING DEPARTMENT. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PRODUCT LIABILITY CLAIM HAS BEEN RELEASED: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ABOUT 8 YEARS AFFTER THE IMPLANTATION DUE TO PATIENT ALLEGATIONS OF INFECTION, PAIN, SWELLING, METALLOSIS AND LOSS OF FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605797 GENERIC CERAMIC HEAD LZO ZIMMER GMBH GENERIC CERAMIC HEAD N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R