BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 41

    MDR report key: 3882224 · Received June 18, 2014

    Report

    Report Number
    1818910-2014-21454
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    June 4, 2014
    Report Date
    August 27, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    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. REF. WWCAPA (B)(4). DEPUY CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. 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 INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING NEW INFORMATION. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    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 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.

    Description of Event or Problem · 1

    UPDATE REC'D 9/27/2016 - MAUDE REPORT STATES 5064621 : "SYMPTOMS OF METAL TOXICITY BEGAN IN 2013 BEGAN POST-OP HIP REPLACEMENT IMPLANTED 2009 (5 YRS), DEPUY ASR HIP, LOSS OF APPETITE, EXTREME WEIGHT AND HAIR LOSS, NIGHTTIME ITCHING, PAIN IN RIGHT SIDE, FATIGUE, TOTAL BODY WEAKENING, AFTER ER VISITS, URGENT CARE CLINIC VISITS YIELDED NO INFORMATION ON PROBLEM. I RESEARCHED METAL ON METAL HIP REPLACEMENT LITIGATION RESULTING FROM THOUSANDS OF PATIENTS HAVING SAME SYMPTOMS. FOUND INFORMATION ON COBALT AND CHROMIUM POISONING, DIAGNOSIS, SURGICAL SOLUTIONS THAT LED ME TO THINK I HAD COBALT, CHROMIUM POISONING. SAW ORTHOPEDIC SURGEON WHO ORDERED MRI MARS, LABORATORY TESTS. RESULTS: ELEVATED COBALT AND CHROMIUM LEVELS: 9.0 COBALT, 6.8 CHROMIUM. REVISION SURGERY RECOMMENDED AND PURSUED TO REMOVE HIP JOINT TOXICITY SOURCE AND REPLACE TOTAL HIP JOINT ((B)(6) 2014). SURGERY MADE JUDGEMENT TO REMOVE FEMORAL HEAD AND REPLACE WITH STRYKER FEMORAL HEAD, NOT TO REPLACE CUP. INEFFECTIVE PT FOR TWO YEARS WITH NO IMPROVEMENT IN HIP STRENGTH. SURGEON WENT IN THROUGH LATERAL APPROACH, AND THEN ANTERIOR, SEVERING PERFORMIS THAT RESULTED IN MORE SEVERE LIMP, BALANCE, FATIGUE, (PERMANENT PROBLEM). LAB TEST RESULTS WERE ELEVATED LEVELS OF COBALT AND CHROMIUM. REVISION OF SUPPOSED REVISION RECOMMENDED, BUT COULDN'T HANDLE THE FEAR AND DEPRESSION. CANCELLED SURGERY ON (B) (6) 2016, WENT TO NEW ORTHOPEDIC SURGEON. NO GUARANTEES WITH SURGERY THAT TOXICITY WIL BE REMOVED. POSSIBILITY OF MEDICAL MISTAKE AND TISSUE INVOLVEMENT, SURGERY ON HOLD. ALL PERTINENT DOCUMENTATION HAS BEEN SUBMITTED TO MEDICARE QUALITY OF CARE DIVISION COMPLAINT THAT HIP WAS NOT REVISED, DISQUALIFIED FROM CLASS ACTION LAWSUIT SUBSEQUENTLY. SURGEON SUBMITTED CLAIM FROM PAYMENT TO MEDICARE FOR TOTAL HIP REPLACEMENT , A NOT REVISED, DISQUALIFIED FROM CLASS ACTION LAWSUIT SUBSEQUENTLY,. SURGEON SUBMITTED CLAIM FROM PAYMENT TO MEDICARE FOR TOTAL HIP REPLACEMENT, A FALSE CLAIM. SURGEON DIDN'T FOLLOW PROTOCOL. I NEED ANOTHER REVISION, AND WORSE SYMPTOMS; FALLING, BALANCE, AND VISUAL DIFFICULT, DEPRESSION. LIMP IS GETTING WORSE. CANE NOT ENOUGH, NEED WALKER. DIAGNOSIS, OR REASON FOR USE: DEFECTIVE HIP JOINT. EVENT ABORTED AFTER USE STOPPED OR DOSE REDUCED: NO."

    Description of Event or Problem · 1

    UPDATE REC'D 08/27/2014- LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN, METAL POISONING, METALLOSIS, METAL DEBRIS, AND ELEVATED METAL IONS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 09/11/2014.

    Description of Event or Problem · 1

    ASR REVISION REPORTED VIA SALES REP: RIGHT HIP. REASON(S) FOR REVISION : PAIN. DER CONFIRMS CUP REMAINED IN SITU. BOTH 41 HEAD AND TAPER SLEEVE REMOVED. NO PRODUCT/LOT NUMBERS PROVIDED.

    Description of Event or Problem · 1

    UPDATE REC'D 08/27/2014- PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB & DOI INFORMATION. PART/LOT WAS IDENTIFIED FROM PATIENT STICKER SHEET THE COMPLAINT AND ASSOCIATED MDR'S WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 09/09/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358525 ASR UNI FEMORAL IMPL SIZE 41 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 2156741

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention