BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 58

    MDR report key: 2915156 · Received January 15, 2013

    Report

    Report Number
    1818910-2013-00388
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    November 26, 2012
    Report Date
    September 18, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z- 1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PATIENT

    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. (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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Additional Manufacturer Narrative · 1

    DEPUY STILL 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 CASE CLOSED TO CAPA.

    Description of Event or Problem · 1

    ADDITIONAL REASON FOR REVISION: NOISE, ALVAL.

    Description of Event or Problem · 1

    ASR REVISION; HIP(S) TO BE REVISED: LEFT; TYPE OF HIP REPLACEMENT PRODUCT: ASR XL; REASON(S) FOR REVISION: PAIN.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION. HIP(S) TO BE REVISED: LEFT. TYPE OF HIP REPLACEMENT PRODUCT: ASR XL. REASON(S) FOR REVISION: PAIN. UPDATE - ADDED A STEM, ADDITIONAL REASON FOR REVISION, PATIENT ID, TAKEN FROM CLAIMSUITE DATED 28TH MARCH 2013. REASON FOR REVISION: NOISE, ALVAL. UPDATE - UPDATED HIP SIDE. TAKEN FROM CLAIMSUITE DATED 18TH SEPTEMBER 2014. RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21626 TOTAL ASR ACET IMP SIZE 58 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 2819907

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention