BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 60

    MDR report key: 2211759 · Received August 10, 2011

    Report

    Report Number
    1818910-2011-14523
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    October 29, 2008
    Report Date
    March 29, 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
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.UPDATED: DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    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.

    Description of Event or Problem · 1

    OPERATIVE REPORT INCLUDED WITH LEGAL CLAIM STATES: ON (B)(6) 2008, PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON THE RIGHT SIDE. ON (B)(6) 2008, PATIENT WAS REVISED DUE TO PAIN. POSSIBLE GRANULOMA FORMATION SECONDARY TO ALLERGIC PHENOMENON WAS DISCOVERED. NONINFLAMMATORY TISSUE NECROSIS WAS PRESENT. THE FEMORAL COMPONENT REMAINED RIGIDLY FIXED AND COULD NOT BE REMOVED. THE BONE BEHIND THE ACETABULUM APPEARED WITHOUT EVIDENCE OF INGROWTH, BUT NO EVIDENCE OF MEMBRANE FORMATION WAS ENCOUNTERED.

    Description of Event or Problem · 1

    UPDATE REC'D 3/29/2013- PPD AND MEDICALRECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY,THE REVISION OPERATIVE NOTE CONFIRMED PAIN AND A LOOSE CUP. THERE IS NO NEWADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 60 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2279864

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention