BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ALLOFIT CUP

    MDR report key: 8599110 · Received May 10, 2019

    Report

    Report Number
    0009613350-2019-00302
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Report Date
    November 19, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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. ADDITIONAL AND CORRECTED INFORMATION ARE FILLED IN THE FOLLOWING FIELDS: 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).

    Additional Manufacturer Narrative · 0

    PRODUCTS IN THIS COMPLAIN DID NOT CONTRIBUTE TO ANY EVENT. THEREFORE COMPLAINT WILL BET SET TO NOT-A-COMPLAIN IN OUR SYSTEM. PLEASE INVALIDATE THIS CASE FROM YOUR SYSTEM. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    IN ADDITION TO THE REPORT 0009613350-2019-00302, WE RECEIVED ADDITIONAL INFORMATION AND IS NOT CLEAR IF PATIENT UNDERWENT REVISION SURGERY (DR HOLTZMAN DID NOT REVISE HIM).

    Additional Manufacturer Narrative · 1

    EXACT DEVICE IDENTIFICATION IS UNKNOWN HOWEVER THIS REPORT IS BEING FILED BECAUSE ZIMMER BIOMET (B)(4) MANUFACTURES AND DISTRIBUTES SIMILAR DEVICES IN THE USA. THE MANUFACTURER RECEIVED X-RAYS AND THEY WILL BE REVIEWED DURING INVESTIGATION. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. THIS IS A SPLIT CASE WITH ZIMMER INC., (B)(4). REFERENCE NUMBER: (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0001822565-2019-01862, 0001822565-2019-01861. 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). REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WILL UNDERGO A REVISION SURGERY DUE TO PAIN. DEVICE HAS BEEN IMPLANTED FOR OVER 20 YEARS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395086 UNKNOWN ALLOFIT CUP N/A KWA ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other UNKNOWN LINER.UNKNOWN STEM.| UNKNOWN LINERUNKNOWN STEM