BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 60

    MDR report key: 2213437 · Received August 12, 2011

    Report

    Report Number
    1818910-2011-15395
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    January 11, 2013
    Report Date
    September 20, 2013
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATON CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HER RIGHT SIDE ON OR ABOUT (B)(6) 2006. SHE LATER EXPERIENCED PAIN AND ELEVATED LEVELS OF COBALT AND CHROMIUM. SHE HAS NOT YET SCHEDULED AN EXPLANTATION OF THE RIGHT ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE - MEDICAL RECORDS RECEIVED (B)(4) 2013. REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: MINIMAL AMOUNT OF FLUID WHICH WAS NORMAL IN APPEARANCE. THERE WAS NO OBVIOUS DAMAGE TO SOFT TISSUES OR BONE BUT THERE WAS HYPERTROPHIC AND AVASCULAR AND PSEUDOCAPSULE. THERE WAS NO SIGN OF ANY OSTEOINTEGRATION OF THE ACETABULAR COMPONENT. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 60 ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL, LTD. NA 1974950

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention