BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 2111395 · Received May 13, 2011

    Report

    Report Number
    1818910-2011-08180
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    April 13, 2011
    Report Date
    August 17, 2014
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    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.

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: BILATERAL PATIENT. LITIGATION PAPERS ALLEGE THAT PATIENT BEGAN TO SUFFER FROM PERSISTENT SEVERE PAIN AND DISCOMFORT IN HIS HIPS, LOWER BACK, LEGS, AND KNEES CAUSED BY THE ASR HIPS WHICH HAS INCREASED OVER TIME. PATIENT SUFFERED AND CONTINUES TO SUFFER SYMPTOMS INCLUDING, BUT NOT LIMITED TO PAIN, ELEVATED COBALT AND CHROMIUM LEVELS, PSEUDO TUMORS, LOOSENING, WEAKNESS, DECREASED RANGE OF MOTIONS, AND DIFFICULTY WITH ACTIVITIES OF DAILY LIVING SUCH AS WALKING AND STANDING AFTER BEING SEATED. THE PAIN AWAKES PATIENT CONTINUOUSLY THROUGH THE NIGHT DISRUPTING HIS SLEEP PATTERNS. PATIENTS IMPLANTS CLICK AND POP. ADDITIONALLY, HE HAS SUFFERED LOSS OF MUSCLE MASS AND DETERIORATION OF SOFT TISSUES. DOCTORS EXAMINED AND ADVISED PATIENT HE SUFFERS FROM SUBSTANTIALLY ELEVATED COBALT AND CHROMIUM METAL IONS IN HIS BLOOD STREAM AND POOLING OF HEAVY METALS AS A RESULT OF THE FAULTY ASR HIP DESIGN. THE INCREASED PRESENCE OF SAID METAL IONS IN THE PATIENTS BLOODSTREAM CAN CAUSE SIGNIFICANT HEALTH PROBLEMS, THE EXACERBATION OF PRE-EXISTING CONDITIONS, WHILE SUBJECTING THE PATIENT TO INCREASED MEDICAL DIAGNOSIS AND TREATMENTS. DOCTORS HAVE ADVISED PATIENT HE SUFFERS FROM PSEUDO TUMORS IN BOTH HIPS WHICH CONTAIN SACKS OF FLUID AROUND HIS JOINTS. DOCTORS ADVISED PATIENT HE WILL NEED TO UNDERGO REVISION SURGERY ON BOTH HIPS, IN THE COMING MONTHS. DOI: (B)(6) 2008 - DOR: NO REVISION REPORTED AT THIS TIME (LEFT SIDE). DOI: (B)(6) 2008 - DOR: NO REVISION REPORTED AT THIS TIME (RIGHT SIDE). PATIENT IS A RESIDENT OF (B)(6). 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT PT BEGAN TO SUFFER FROM PERSISTENT SEVERE PAIN AND DISCOMFORT IN HIS HIPS, LOWER BACK, LEGS, AND KNEES CAUSED BY THE ASR HIPS WHICH HAS INCREASED OVER TIME. PT SUFFERED AND CONTINUES TO SUFFER SYMPTOMS INCLUDING, BUT NOT LIMITED TO PAIN, ELEVATED COBALT AND CHROMIUM LEVELS, PSEUDO TUMORS, LOOSENING, WEAKNESS, DECREASED RANGE OF MOTIONS, AND DIFFICULTY WITH ACTIVITIES OF DAILY LIVING SUCH AS WALKING AND STANDING AFTER BEING SEATED. THE PAIN AWAKES PT CONTINUOUSLY THROUGH THE NIGHT DISRUPTING HIS SLEEP PATTERNS. PT'S IMPLANTS CLICK AND POP. ADDITIONALLY, HE HAS SUFFERED LOSS OF MUSCLE MASS AND DETERIORATION OF SOFT TISSUES. DOCTORS EXAMINED AND ADVISED PT HE SUFFERS FROM SUBSTANTIALLY ELEVATED COBALT AND CHROMIUM METAL IONS IN HIS BLOOD STREAM AND POOLING OF HEAVY METALS AS A RESULT OF THE FAULTY ASR HIP DESIGN. THE INCREASED PRESENCE OF SAID METAL IONS IN THE PT'S BLOODSTREAM CAN CAUSE SIGNIFICANT HEALTH PROBLEMS, THE EXACERBATION OF PRE-EXISTING CONDITIONS, WHILE SUBJECTING THE PT TO INCREASED MEDICAL DIAGNOSIS AND TREATMENTS. DOCTORS HAVE ADVISED PT HE SUFFERS FROM PSEUDO TUMORS IN BOTH HIPS WHICH CONTAIN SACKS OF FLUID AROUND HIS JOINTS. DOCTORS ADVISED PT HE WILL NEED TO UNDERGO REVISION SURGERY ON BOTH HIPS, IN THE COMING MONTHS. DOI: (B)(6) 2008 - DOR: NO REVISION REPORTED AT THIS TIME. (LEFT SIDE). DOI: (B)(6) 2008 - DOR: (B)(4) 2011 (RIGHT SIDE). PT IS A RESIDENT OF AL. UPDATE: (B)(6) 2011 - THE SALES REP REPORTED THE RIGHT HIP REVISION. PT WAS REVISED TO ADDRESS PAIN. PART/LOT NUMBERS IDENTIFIED FOR THE RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 47 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2625244

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention