BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR 300 SPIKED CUPS 46

    MDR report key: 2113397 · Received May 20, 2011

    Report

    Report Number
    1818910-2011-08888
    Event Type
    Injury
    Date Received
    May 20, 2011
    Report Date
    December 16, 2015
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    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

    UPDATE: (B)(6) 2013 - PPD RECEIVED. PART/LOT AND DOB INFORMATION HAVE BEEN UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY CONSIDERS THIS COMPLAINT CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    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). 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    Description of Event or Problem · 1

    UPDATE-- 12/16/2015- DOR RECEIVED. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE SINCE SURGICAL IMPLANTATION, PT HAS SUFFERED SYMPTOMS INCLUDING, BUT NOT LIMITED TO PAIN, SORENESS AND DIFFICULTY WALKING. IT IS FURTHER ALLEGED THE PT HAS SUFFERED SIGNIFICANT HARM, INCLUDING BUT NOT LIMITED TO, PHYSICAL INJURY AND BODILY IMPAIRMENT, DEBILITATING LACK OF MOBILITY AND CONSCIOUS PAIN AND SUFFERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR 300 SPIKED CUPS 46 TOTAL HIP REPLACEMENT KWA DEPUY INTL., LTD. NA 2708625

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention