BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 58

    MDR report key: 2213944 · Received August 12, 2011

    Report

    Report Number
    1818910-2011-14860
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    June 8, 2015
    Report Date
    June 8, 2015
    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
    VA, 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

    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

    DEPUY STILL 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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.

    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 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

    (B)(4). 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 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 THE PATIENT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJURY (IES) AS A RESULT OF THE IMPLANTATION OF THE ASR HIP IMPLANT: COBALT AND/OR CHROMIUM POISONING, PAIN, SUFFERING, OCCASIONAL DISLOCATION OF THE LEFT HIP, NUMEROUS FOLLOW-UP DOCTOR VISITS, POSSIBLE REVISION, ANXIETY, FEAR, MENTAL ANGUISH AND OTHER EMOTIONAL AND PHYSICAL DAMAGES.

    Description of Event or Problem · 1

    UPDATE REC'D 6/8/2015 SALES REP REPORTED REVISION SURGERY. PATIENT REVISED TO ADDRESS PAIN. MANUFACTURING AND EXPIRATION DATES UPDATED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

    Description of Event or Problem · 1

    UPDATE 1/18/2016 & 1/19/2016 MEDICAL RECORDS RECEIVED. AMENDED COMPLAINT AND MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. AMENDED COMPLAINT NOTED PAIN, SUFFERING, MENTAL ANGUISH, AND MEDICAL EXPENSES. REVISION SURGICAL REPORT NOTED SYNOVITIS, INCREASED CHROMIUM COBALT LEVELS WITHOUT LAB RESULTS, BROWN-TINGED TISSUE AND BURSAL IRRITATION. AN UNKNOWN STEM AND SLEEVE WILL BE ADDED FOR THE ALLEGED ELEVATED CHROMIUM COBALT LEVELS. THE COMPLAINT WAS UPDATED ON: FEB 5, 2016.

    Description of Event or Problem · 1

    UPDATE 03/31/2016: SUPPLEMENTAL INFORMATION RECEIVED. PRODUCT IDENTIFICATION FOR THE STEM AND SLEEVE WAS RECEIVED. FOLLOW-UP MW TO BE SENT AND COMPLAINT TO BE BACK TO INVESTIGATION PHASE. THE COMPLAINT WAS UPDATED ON: 04/19/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 58 ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL, LTD. NA 2623979

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention