BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 41

    MDR report key: 3143476 · Received June 3, 2013

    Report

    Report Number
    1818910-2013-18082
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    March 26, 2013
    Report Date
    January 29, 2017
    Manufacturer
    DEPUY INTERNATIONAL LTD.8010379
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. (B)(4).  THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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

    PATIENT'S REVISION OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION A LARGE CYST AND SIGNIFICANT AMOUNTS OF METALLOSIS WERE FOUND THROUGHOUT THE AREA OF THE JOINT. THE FEMORAL HEAD WAS ADDED TO THE COMPLAINT AND THE COMPLAINT REOPENED.

    Description of Event or Problem · 1

    UPDATE REC¿D 02/20/2014 - LEGAL CLAIM WAS RECEIVED, WHICH IDENTIFIED DOB INFORMATION. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 06/17/2014.

    Description of Event or Problem · 1

    UPDATE REC'D 06/24/2015 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 07/07/15.

    Description of Event or Problem · 1

    UPDATE (1/29/2017). MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, REVISION OPERATIVE NOTE STATED "SIGNIFICANT AMOUNTS OF METALLOSIS WAS FOUND" AND IDENTIFIED A "LARGE PSEUDOTUMOR INVADING...PARTS OF THE ACETABULUM" AND "METALLOSIS INVADING CYSTS IN THE DOME OF THE ACETABULUM". THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Description of Event or Problem · 1

    UPDATE MAY 29, 2017: SUPPLEMENTAL INFORMATION RECEIVED. REVISION OPERATIVE NOTE REPORTED SIGNIFICANT AMOUNT OF METALLOSIS FOUND UPON ENTERING THE JOINT AND AROUND THE TROCHANTERIC REGION. THERE WAS ALSO CYSTIC CHANGES NOTED, AND A LARGE PSEUDOTUMOR WAS FOUND AROUND THE ACETABULUM. IT ALSO STATED THAT THE ACETABULAR COMPONENT WAS FOUND TO BE GROSSLY LOOSE AND VERTICAL AND THERE WERE SOME SUPERIOR AND POSTERIOR BONE LOSS IN THE ACETABULAR BONE. EXAMINATION NOTES REPORTED PAIN AND HIGH METAL LEVELS. LABORATORY VALUES OF COBALT AND CHROMIUM WERE ABOVE 7 PPB. STEM AND SLEEVE WERE ADDED DUE TO THE REPORTED HIGH METAL LEVELS. NO LOT INFORMATION PROVIDED. THIS COMPLAINT WAS UPDATED ON: JUN 1, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243480 DEPUY ASR XL FEM IMP SIZE 41 HEAD KXA DEPUY INTERNATIONAL LTD.8010379 2362987

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention