BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES 12/14 +8

    MDR report key: 5201385 · Received November 4, 2015

    Report

    Report Number
    1818910-2015-34424
    Event Type
    Injury
    Date Received
    November 4, 2015
    Date of Event
    October 13, 2015
    Report Date
    October 19, 2015
    Manufacturer
    DEPUY INTL.,LTD 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    AGE: (B)(6). DATE RECEIVED BY MFR: 2/19/2016. UPDATE 2/19/16 MEDICAL RECORDS RECEIVED. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PART/LOT UPDATED. THE COMPLAINT WAS UPDATED ON: MAR 2, 2016. DEVICE NAME: ADAPTER SLEEVES 12/14 +8. COMMON DEVICE NAME: FDA CODE: 87KWA. PART NUMBER: 999800318. LOT NUMBER: 2639662. PMA/510(K): K040627. DATE RECEIVED BY MFR: 5/16/2008. (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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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. REF. (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.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT SUFFERS FROM PAIN. UPDATE (B)(6) 2015 - LITIGATION RECEIVED. LITIGATION ALLEGES PATIENT SUFFERS FROM ELEVATED COBALT CHROMIUM METAL IONS. THE SLEEVE AND STEM ARE NOW BEING REPORTED.

    Description of Event or Problem · 1

    UPDATE 2/19/16 MEDICAL RECORDS RECEIVED. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PART/LOT UPDATED. THE COMPLAINT WAS UPDATED ON: MAR 2, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732713 ADAPTER SLEEVES 12/14 +8 HIP FEMORAL STEM/SLEEVE KWA DEPUY INTL.,LTD 8010379 2639662

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention