BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR FEMORAL HEAD

    MDR report key: 4061442 · Received September 4, 2014

    Report

    Report Number
    1818910-2014-27294
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 2, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.-8010379
    Product Code
    KXA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    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 THIS 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.(B)(4). DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    ASR REVISION REPORTED VIA SALES REP; ASR XL; RIGHT; REASON(S) FOR REVISION : PAIN.

    Description of Event or Problem · 1

    UPDATE REC'D 9/2/2014 - MEDICAL RECORDS RECEIVED. UPON REVISION, SOFT TISSUE REACTION TO METAL ON METAL, BONE LOSS, METAL STAINED TISSUE, A LARGE FLUID COLLECTION, AND ACETABULAR LOOSENING WERE NOTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON: 09/10/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542863 UNKNOWN DEPUY ASR FEMORAL HEAD HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD.-8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention