BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES

    MDR report key: 5405084 · Received February 2, 2016

    Report

    Report Number
    1818910-2016-12493
    Event Type
    Injury
    Date Received
    February 2, 2016
    Date of Event
    March 26, 2015
    Report Date
    February 1, 2016
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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.

    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. UDI: UNAVAILABLE. 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

    DATE OF BIRTH: (B)(6) 1931. DATE RECEIVED BY MFR: 2/15/2016. UPDATE 2/15/16 MEDICAL RECORDS RECEIVED. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PPD REVIEWED AND PATIENT DOB UPDATED. STICKER SHEET ATTACHED AND PART/LOT UPDATED. THE COMPLAINT WAS UPDATED ON: FEB 29, 2016 . PRODUCT: 999800318 MDR : 249169 BRAND NAME: ADAPTER SLEEVES 12/14 +8. COMMON DEVICE NAME: FDA CODE: 87KWA. PART NUMBER: 999800318. LOT NUMBER: 2100030. PMA/510(K): K040627. DATE RECEIVED BY MFR: 3/23/2006. (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

    ASR REVISION. ASR XL - LEFT HIP, REASON FOR REVISION: INFECTION, SURGEON REMOVED INFECTED ASR/AML. UPDATE REC'D 2/1/2016: LITIGATION RECEIVED. LITIGATION ALLEGES PAIN, INFECTION, AND ELEVATED METAL IONS. A DOI WAS PROVIDED. ALL IMPLANTS ARE NOW BEING REPORTED. THIS COMPLAINT WAS UPDATED ON: 2/2/2016.

    Description of Event or Problem · 1

    UPDATE 2/15/16 MEDICAL RECORDS RECEIVED. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PPD REVIEWED AND PATIENT DOB UPDATED. STICKER SHEET AND PART/LOT UPDATED. THE COMPLAINT WAS UPDATED ON: FEB 29, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61751 ADAPTER SLEEVES HIP FEMORAL STEM/SLEEVE KWA DEPUY INTL.,LTD 8010379 2100030

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention