BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 43

    MDR report key: 5194621 · Received November 2, 2015

    Report

    Report Number
    1818910-2015-34223
    Event Type
    Injury
    Date Received
    November 2, 2015
    Date of Event
    May 20, 2010
    Report Date
    October 30, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWY
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    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. 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. 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

    ASR REVISION RIGHT XL REASON FOR REVISION : PAIN THIS COM IS THE FIRST OF 2 SURGERIES. FOR THE SECOND SURGERY PLEASE SEE COM 142900 UPDATE OCT 9, 2017: MEDICAL RECORD RECEIVED. IN ADDITION TO WHAT PREVIOUSLY ALLEGES, PATIENT ALSO ALLEGES NOISE IN THE OPERATED HIP. THIS COMPLAINT WAS UPDATED ON OCT 23, 2017.. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. 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

    ASR REVISION, RIGHT, XL, REASON FOR REVISION : PAIN. THIS COM IS THE FIRST OF 2 SURGERIES. FOR THE SECOND SURGERY PLEASE SEE (B)(4).

    Description of Event or Problem · 1

    UPDATE OCT 9, 2017: MEDICAL RECORD RECEIVED. IN ADDITION TO WHAT PREVIOUSLY ALLEGES, PATIENT ALSO ALLEGES NOISE IN THE OPERATED HIP. THIS COMPLAINT WAS UPDATED ON OCT 23, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725770 DEPUY ASR XL FEM IMP SIZE 43 HIP FEMORAL HEAD KWY DEPUY INTERNATIONAL LTD. 8010379 2924849

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention