BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 51

    MDR report key: 4090999 · Received September 16, 2014

    Report

    Report Number
    1818910-2014-28097
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    June 10, 2014
    Report Date
    September 19, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    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

    DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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.

    Description of Event or Problem · 1

    ASR REVISION.ASR RESURFACING - LEFT.REASON FOR REVISION: UNKNOWN.THIS IS THE FIRST PART OF A RESURFACING TO XL REVISION. CUP REMAINED IN SITU.CUP AND RESURFACING HEAD IMPLANTED ON (B)(6) 2006.RESURFACING HEAD REVISED ON (B)(6) 2007. XL PRODUCTS IMPLANTED.CUP AND XL PRODUCTS REVISED ON (B)(6) 2014. PLEASE SEE COM (B)(4) FOR REVISION OF THE CUP.

    Description of Event or Problem · 1

    ASR REVISION. ASR RESURFACING - LEFT. REASON FOR REVISION: UNKNOWN. THIS IS THE FIRST PART OF A RESURFACING TO XL REVISION. CUP REMAINED IN SITU. CUP AND RESURFACING HEAD IMPLANTED ON (B)(6) 2006. RESURFACING HEAD REVISED ON (B)(6) 2007. XL PRODUCTS IMPLANTED. CUP AND XL PRODUCTS REVISED ON (B)(6) 2014. PLEASE SEE (B)(4) FOR REVISION OF THE CUP. QUERY RESPONSE RECEIVED 19TH SEPTEMBER 2014. REASON FOR REVISION ADDED. REASON FOR REVISION: ASEPTIC NECROSIS OF THE LEFT FEMORAL HEAD AND NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571282 TOTAL ASR FEM IMP SIZE 51 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 8010379 2234487

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention