BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 46

    MDR report key: 3062015 · Received April 16, 2013

    Report

    Report Number
    1818910-2013-04840
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    May 6, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. REF. (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 CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    **UPDATE**(B)(4) 2013 - MEDICAL DECLARATION AND DECONTAMINATION SHEET WERE RECEIVED. DOR WAS ALSO GIVEN. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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, TROUBLE WALKING, METALLOSIS, IMPAIRMENT, AND DISFIGUREMENT AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    **UPDATE**(B)(4) 2013 - MEDICAL DECLARATION AND DECONTAMINATION SHEET WERE RECEIVED. DOR WAS ALSO GIVEN. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN, TROUBLE WALKING, METALLOSIS, IMPAIRMENT, AND DISFIGUREMENT AFTER ASR HIP IMPLANT. UPDATE: (B)(6) 2013- MEDICAL DECLARATION AND DECONTAMINATION SHEET WERE RECEIVED. DOR WAS ALSO GIVEN. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: (B)(6) 2013 - PLAINTIFFS PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION AND CORRECT IMPLANT DATE FOR THE RIGHT SIDE. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162589 TOTAL ASR FEM IMP SIZE 46 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 1182023

    Patients

    Seq Age Sex Outcome Treatment
    1 Other