BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 10

    MDR report key: 3081180 · Received April 26, 2013

    Report

    Report Number
    1818910-2013-05120
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    April 26, 2010
    Report Date
    November 21, 2014
    Manufacturer
    DEPUY FRANCE SAS-3003895575
    Product Code
    MEH
    PMA / PMN Number
    K042992
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    ATTORNEY

    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).

    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

    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

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION ON THE RIGHT HIP IMPLANT. THE REASON FOR THE REVISION IS UNKNOWN.

    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, ASR XL - RIGHT, REASON(S) FOR REVISION: UNKNOWN. THIS WAS A RESURFACING TO XL PROCEDURE - FOR 1ST REVISION. THE CUP WAS IMPLANTED IN (B)(6) 2009. THE HEAD, STEM AND SLEEVE WERE IMPLANTED (B)(6) 2009 AND THE CUP REMAINED IN SITU. ALL PRODUCTS INCLUDING CUP REVISED (B)(6) 2010. INVALID LOT NUMBER PROVIDED FOR XL HEAD 2431329. UPDATE 21 NOV 2014 - REASONS FOR REVISION: PAIN & ALVAL/SOFT TISSUE REACTION, REVISION SURGEON: MR (B)(6), CUP PRODUCT DETAILS, CORRECT LOT NUMBER (AND PRODUCT CODE) FOR HEAD, FILE HANDLER: (B)(6), HOSPITAL: (B)(6). THIS WAS A RESURFACING TO XL OPERATION. (B)(4) FOR THE RESURFACING REVISION. AS THE CUP REMAINED IN SITU FROM THE FIRST REVISION, THERE ARE 2 IMPLANT DATES: (B)(6) 2009 (RESURFACING IMPLANT) AND (B)(6) 2009 (XL IMPLANT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182279 CORAIL2 NON COL HO SIZE 10 HIP FEMORAL STEM/SLEEVE MEH DEPUY FRANCE SAS-3003895575 2529065

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention