BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LINER

    MDR report key: 6578875 · Received May 19, 2017

    Report

    Report Number
    0001825034-2017-03312
    Event Type
    Injury
    Date Received
    May 19, 2017
    Date of Event
    April 24, 2017
    Report Date
    September 21, 2017
    Manufacturer
    .
    Product Code
    KWA
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IMPLANT DATE- 2003. CONCOMITANT PRODUCTS: UNKNOWN HEAD, UNKNOWN CUP, UNKNOWN STEM. THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-03311-2

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS COMPLAINT WAS FOR A REQUEST FOR PRODUCT IDENTIFICATION ONLY. THERE WAS NO ALLEGED DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS OR PERFORMANCE OF THE PRODUCT. AS SUCH, THIS INFORMATION IS CONSIDERED AN INQUIRY AND THE COMPLAINT FILE IS BEING CLOSED AS NOT A COMPLAINT. IF ADDITIONAL INFORMATION IS RECEIVED THAT ALLEGES A PRODUCT DEFICIENCY, THE COMPLAINT WILL BE RE-OPENED AND EVALUATED AT THAT TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN HEAD, UNKNOWN CUP, UNKNOWN STEM. THE INVESTIGATION IS STILL IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED WITH THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001825034-2017-03311, 0001825034-2017-03313 0001825034-2017-03314.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE ITEM AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. REVIEW OF PROVIDED X-RAYS BY RADIOLOGIST IDENTIFIED THE FEMORAL HEAD COMPONENT IS ECCENTRICALLY LOCATED SUPER LATERALLY WITHIN THE ACETABULAR CUP, CONSISTENT WITH SUPERIOR ACETABULAR CUP POLYETHYLENE LINER WEAR. ROOT CAUSE COULD NOT BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS ABLE TO BE CONFIRMED VIA OPERATIVE NOTES RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 14 YEARS POST INITAL IMPLANTATION DUE TO WEAR. IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF DISLOCATIONS ON UNKNOWN DATES. RADIOGRAPHS REVEALED THAT THERE WAS ASYMMETRIC WEAR OF THE POLY LINER. INSTABILITY WAS SAID TO BE RELATED TO EXCESSIVE WEAR OF THE POLYETHYLENE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359208 UNKNOWN LINER PROSTHESIS, HIP KWA . N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| O| R