BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR 300 SPIKED CUP SIZE 48

    MDR report key: 3121561 · Received May 21, 2013

    Report

    Report Number
    1818910-2013-05967
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    June 22, 2016
    Report Date
    May 16, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK073413
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT IS CONSIDERED CLOSED.

    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

    (B)(4). ADDED: PATIENT, DEVICE.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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 ALLEGES PATIENT HAD PAIN AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE JUL 10, 2017: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR THE MDR REPORTABILITY, PATIENT WAS REVISED DUE TO FAILED TOTAL HIP ARTHROPLASTY. REVISION NOTES STATED THAT THERE WAS SIGNIFICANT GREEN-GRAY FLUID WITHIN THE JOINT. THE JOINT LINING WAS ALSO STAINED GREEN AND GRAY. IT WAS ALSO STATED THAT THERE WAS SIGNIFICANT AMOUNT OF METAL BUILD-UP AND TRUNNIONOSIS IN THE FEMORAL HEAD. IT WAS REPORTED IN THE MEDICAL RECORDS , ELEVATED METAL IONS, HOWEVER, THERE WERE NO LABORATORY VALUES PROVIDED. ADDED STEM AND SLEEVE TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON JUL 11, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224146 ASR 300 SPIKED CUP SIZE 48 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 2712639

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other