BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 12

    MDR report key: 3831541 · Received May 25, 2014

    Report

    Report Number
    1818910-2014-19433
    Event Type
    Injury
    Date Received
    May 25, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 5, 2015
    Manufacturer
    DEPUY FRANCE SAS
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: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. (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

    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.

    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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    ASR REVISION.ASR XL.LEFT.REASON(S) FOR REVISION: PAIN.

    Description of Event or Problem · 1

    ASR REVISION. ASR XL. LEFT. REASON(S) FOR REVISION: PAIN. UPDATE REC'D 28TH JULY 28 JULY 2014 - LEGAL NOTIFICATION THAT PATIENT UNDERWENT 1ST REVISION SURGERY THE DAY AFTER THE ORIGINAL IMPLANT DUE TO LATERAL CORTICAL PERFORATION. THE CUP REMAINED IN SITU AND WAS REVISED ON (B)(6) 2014. (B)(4). UPDATE 12 AUG 2014 - 10 X CDS ARRIVED WITH MEDICAL RECORDS AND X-RAYS - UNFORTUNATELY THEY ARE NOT FOR THE REVISION SURGERY PERIODS - PATIENT DEMO'S ADDED.

    Description of Event or Problem · 1

    ASR REVISION, ASR XL, LEFT, REASON(S) FOR REVISION: PAIN. UPDATE REC'D (B)(6) 2014 - LEGAL NOTIFICATION THAT PATIENT UNDERWENT 1ST REVISION SURGERY THE DAY AFTER THE ORIGINAL IMPLANT DUE TO LATERAL CORTICAL PERFORATION. THE CUP REMAINED IN SITU AND WAS REVISED ON (B)(6) 2014 SEE COM (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309751 CORAIL2 STD SIZE 12 HIP FEMORAL STEM/SLEEVE KXA DEPUY FRANCE SAS 2480302

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention