BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 62

    MDR report key: 2002935 · Received February 16, 2011

    Report

    Report Number
    1818910-2011-02481
    Event Type
    Injury
    Date Received
    February 16, 2011
    Report Date
    July 2, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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.

    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).

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    ***ADDENDUM ADDED 04 JUL 2017*** THE COMPLAINT WAS REOPENED AS ADDITIONAL INFORMATION RECEIVED FROM (B)(6), AS PER REVIEW OF THE NEW INFORMATION THERE IS NO UPDATE TO THE COM. NO FURTHER ACTIONS IDENTIFIED. 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. 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

    PT SUFFERS AND NEED TO BE RE-OPERATED. PER SURGEON LETTER DATED (B)(6) 2011, THE PT HAS PAIN MOST LIKELY FROM METAL DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 62 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. NA 2332882

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention