BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES 12/14 +2

    MDR report key: 4171600 · Received October 14, 2014

    Report

    Report Number
    1818910-2014-29931
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 22, 2014
    Report Date
    November 7, 2014
    Manufacturer
    DEPUY INTERNATIONAL 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
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 THIS 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.(B)(4). DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    UPDATE REC'D 11/7/2014 - MEDICAL RECORDS RECEIVED. PATIENT REVISED TO ADDRESS DISABILITY, METAL WEAR AND SYNOVITIS. UPON REVISION, A CYSTIC FORMATION, THICK, MURKY FLUID, METALLOSIS, NECROTIC DEBRIS, CORROSION ON THE TAPER, NO BONE ATTACHED TO THE ACETABULAR CUP, BONE LOSS IN THE POSTERIOR WALL OF THE ACETABULUM AND GRAYISH-BROWNISH MATERIAL IMBEDDED WITHIN THE JOINT. THE STEM REMAINED IN SITU. THE STEM IS BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: 12/02/2014.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT: LITIGATION ALLEGES THAT PATIENT HAS EXPERIENCED ELEVATED LEVELS OF CHROMIUM AND COBALT. DOI: (B)(6) 2007 - DOR: NONE REPORTED (RIGHT HIP). PATIENT IS A RESIDENT OF (B)(6). UPDATE 13 OCT 2014 - DER RCVD VIA SALES REP. UPDATED DOR, SURGEON, SALES REP INFO, PATIENT AGE, HEIGHT, WEIGHT AND ACTIVITY LEVEL. ADDED SLEEVE PRODUCT AND ADDED PAIN AND CLICKING TO REASONS FOR REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650115 ADAPTER SLEEVES 12/14 +2 HIP OTHER IMPLANT KWA DEPUY INTERNATIONAL LTD.-8010379 2459156

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention