BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADAPTER SLEEVE 11/13 +6

    MDR report key: 6170917 · Received December 13, 2016

    Report

    Report Number
    1818910-2016-33369
    Event Type
    Death
    Date Received
    December 13, 2016
    Report Date
    January 27, 2017
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN. THE INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS WAS CONDUCTED UNDER MDD CAPA-(B)(4). ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT. DEVICE HISTORY LOT: NULL. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    UPDATE 01/27/2017 ¿ MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. UPDATED EXP. DATES ON TWO PRODUCTS.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGAL SYSTEM) COMPLAINT NUMBER (B)(4)REASON FOR ORIGINAL COMPLAINT ¿ LITIGATION PAPERS ALLEGE PAIN AND PROBLEMS. ADDITIONALLY IT IS ALLEGED THE PATIENT WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT. UPDATE: 12/6/2011 PLAINTIFF FACT SHEET RECEIVED WITH PART/LOT INFORMATION. THIS INFORMATION DOES NOT CHANGE THE INVESTIGATIONAL RESULTS. UPDATE ¿11/22/2016 MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, ADDING STEM AND SLEEVE DUE TO ALLEGED ELEVATED METAL ION LEVELS. THE COMPLAINT WAS UPDATED ON: 12/13/2016

    Description of Event or Problem · 1

    PFS AND MEDICAL RECORDS RECEIVED. PFS STATED ON THE EMAIL, THAT THE PATIENT RECENTLY PASSED AWAY. ON (B)(6) 2014, PATIENT WAS REFERRED TO A REVISION SURGEON, BUT IT WAS STILL CONTRA-INDICATED BECAUSE OF UNDERLYING MEDICAL CONDITIONS, INCLUDING RECURRENT THROMBOEMBOLIC EVENTS AND HISTORY OF MYOCARDIAL INFARCTION. WITH CONSTANT SOURCE OF PAIN, PATIENT DEVELOPED SUICIDAL IDEATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822091 ADAPTER SLEEVE 11/13 +6 HIP OTHER IMPLANT KWA DEPUY INTERNATIONAL LTD - 8010379 2142136

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O