BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1818910-2019-102871

    MDR report key: 8956663 · Received September 3, 2019

    Report

    Report Number
    1818910-2019-102871
    Event Type
    Injury
    Date Received
    September 3, 2019
    Date of Event
    July 12, 2019
    Report Date
    August 13, 2019
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. WWCAPA (B)(4) SUPERSEDED BY MDD CAPA-(B)(4). NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. (B)(4). 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

    SURGEON CONFIRMATION FORM AND CLAIMSUITE ALERT RECORDS RECEIVED. SCF AND CLAIMSUITE ALERTS ALLEGES ALVAL/SOFT TISSUE REACTION AND HIGH LEVEL OF METAL IONS. DOI: (B)(6) 2009; DOR: (B)(6) 2019,: RIGHT.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention