BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 2142942 · Received June 23, 2011

    Report

    Report Number
    1818910-2011-11125
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 14, 2014
    Report Date
    July 9, 2014
    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
    CA, 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

    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

    CORRECTED: EVENT/PROBLEM DESCRIPTION, BRAND NAME, DEVICE PRODUCT CODE, CATALOG #/LOT #, DATE RECEIVED BY MANUFACTURER, PMA/510(K) #, MANUFACTURE DATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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 INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. 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

    LITIGATION PAPERS ALLEGE PATIENT HAS SUFFERED SIGNIFICANT HARM, INCLUDING, BUT NOT LIMITED TO, PHYSICAL INJURY, PAIN, BODILY IMPAIRMENT, HIGH LEVELS OF TOXIC METAL IN HIS BLOOD STREAM, CONSCIOUS PAIN AND SUFFERING, AND LOSS OF EARNINGS. IT IS FURTHER ALLEGED PATIENT IS INFORMED AND BELIEVES THAT HE WILL BE REQUIRED TO UNDERGO A SURGICAL REVISION. AS A RESULT OF THAT REVISION SURGERY, PATIENT WILL SUFFER HARM, INCLUDING, BUT NOT LIMITED TO, PHYSICAL INJURY, BODILY IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, CONSCIOUS PAIN, AND SUFFERING AND LOSS OF EARNINGS. UPDATE: (B)(4) 2011 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    UPDATE REC'D 07/09/2014 - MEDICAL RECORDS RECEIVED. PATIENT REVISED TO ADDRESS AN OSTEOLYTIC LESION. UPON REVISION, A PHYSIOLOGIC-APPEARING GREATER TROCHANTERIC BURSA WHICH DID NOT COMMUNICATE WITH THE JOINT, APPROXIMATELY 15 CC OF GRAY BROWN FLUID, AND A CHALKY AMORPHOUS GRAY MATERIAL FILLING THE HIP WERE NOTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON: 07/21/2014.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - LITIGATION PAPERS ALLEGE PATIENT HAS SUFFERED SIGNIFICANT HARM, INCLUDING, BUT NOT LIMITED TO, PHYSICAL INJURY, PAIN, BODILY IMPAIRMENT, HIGH LEVELS OF TOXIC METAL IN HIS BLOOD STREAM, CONSCIOUS PAIN AND SUFFERING, AND LOSS OF EARNINGS. IT IS FURTHER ALLEGED PATIENT IS INFORMED AND BELIEVES THAT HE WILL BE REQUIRED TO UNDERGO A SURGICAL REVISION. AS A RESULT OF THAT REVISION SURGERY, PATIENT WILL SUFFER HARM, INCLUDING, BUT NOT LIMITED TO, PHYSICAL INJURY, BODILY IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, CONSCIOUS PAIN, AND SUFFERING AND LOSS OF EARNINGS. DOI: (B)(6) 2007 - DOR: NO REVISION REPORTED AT THIS TIME. (RIGHT SIDE). PATIENT IS A RESIDENT OF (B)(6). UPDATE 9/28/11 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDR'S WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE 14 MAY 2014 - DER RCVD - UPDATED SURGEON / HOSPITAL / DOR AND PRODUCT INFORMATION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT HAS SUFFERED SIGNIFICANT HARM, INCLUDING, BUT NOT LIMITED TO, PHYSICAL INJURY, PAIN, BODILY IMPAIRMENT, HIGH LEVELS OF TOXIC METAL IN HIS BLOOD STREAM, CONSCIOUS PAIN AND SUFFERING, AND LOSS OF EARNINGS. IT IS FURTHER ALLEGED PATIENT IS INFORMED AND BELIEVES THAT HE WILL BE REQUIRED TO UNDERGO A SURGICAL REVISION. AS A RESULT OF THAT REVISION SURGERY, PATIENT WILL SUFFER HARM, INCLUDING, BUT NOT LIMITED TO, PHYSICAL INJURY, BODILY IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, CONSCIOUS PAIN, AND SUFFERING AND LOSS OF EARNINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 56 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL, LTD NA 2380685

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention