BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 58

    MDR report key: 2011304 · Received March 4, 2011

    Report

    Report Number
    1818910-2011-02998
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    August 24, 2006
    Report Date
    June 26, 2012
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Additional Manufacturer Narrative · 1

    THE ACETABULAR CUP WAS NON CONTRIBUTING TO THE EVENT AS THE CUP REMAINS IN THE PATIENT. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    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

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: 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. THE INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS WAS CONDUCTED UNDER MDD CAPA-001226. ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT. PREVIOUS INVESTIGATIONS THAT HAVE INCLUDED DEVICE HISTORY REVIEWS SINCE THE ASR PLATFORM WAS LAUNCHED HAVE SHOWN NO INDICATION OF DEVIATIONS OR ANOMALIES WITH REGARD TO MATERIAL, MANUFACTURING OR INSPECTION. THEREFORE NO DHR (DEVICE HISTORY RECORD) REVIEW FOR THIS INDIVIDUAL ASR COMPONENT WILL BE CARRIED OUT AT THIS POINT IN TIME. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. THE INVESTIGATION TO DETERMINE ROOT CAUSE WAS CONDUCTED UNDER MDD CAPA-001226. ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    REASON(S) FOR REVISION: COMPONENT MALPOSITIONING.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM FILE HANDLER STATED, "THE PATIENT HAS BEEN REVISED FROM A DEPUY ASR RESURFACING TO A DEPUY ASR XL PROTHESIS ON (B)(6) 2006 DUE TO PAIN AND COMPONENT MALALIGNMENT.. THE ASR XL PROTHESIS IS STILL IN PLACE AND HAS NOT BEEN REVISED YET. " ADDED PATIENT CODE FOR PAIN.

    Description of Event or Problem · 1

    THE PATIENT HAS HAD AN ASR REVISION. SPECIFIC DETAILS REGARDING THE REPORT ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR IMPLANT 58 ACETABULAR IMPLANT KWA DEPUY INTERNATIONAL LTD - 8010379 NA 1867394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention