BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 56

    MDR report key: 3191645 · Received June 26, 2013

    Report

    Report Number
    1818910-2013-19952
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    October 26, 2012
    Report Date
    February 2, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KWA
    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

    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.

    Description of Event or Problem · 1

    ASR REVISION; RIGHT; RESURFACING; REASON FOR REVISION: UNKNOWN.

    Description of Event or Problem · 1

    ASR REVISION, RIGHT, RESURFACING, REASON FOR REVISION: UNKNOWN. UPDATE 27 AUG 2014 - (B)(4). ADDING PAIN AND NOISE AS REASONS FOR REVISION. XL NOT RESURFACING AS PREVIOUSLY REPORTED. ADDED SURGEON. SLEEVE AND STEM ADDED. UPDATE - ADDED PATIENT DATE OF BIRTH, MARKED AS LEGAL, ADDED KID NUMBER, ADDED ALL EXPIRY DATES AND ATTACHED LEGAL LETTER TO THE COM. TAKEN FROM EMAIL DATED 2ND FEB 2015. PATIENT DATE OF BIRTH - (B)(6) 1935, (B)(6).

    Description of Event or Problem · 1

    ASR REVISION.RIGHT.RESURFACING.REASON FOR REVISION: UNKNOWN.UPDATE 27 AUG 2014 - SCF ATTACHED. ADDING PAIN AND NOISE AS REASONS FOR REVISION. XL NOT RESURFACING AS PREVIOUSLY REPORTED. ADDED SURGEON. SLEEVE AND STEM ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290197 TOTAL ASR ACET IMP SIZE 56 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 1194861

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention