BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 57

    MDR report key: 2915167 · Received January 15, 2013

    Report

    Report Number
    1818910-2013-00929
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    November 19, 2012
    Report Date
    May 15, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    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

    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. REF. (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

    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

    ADDITIONAL NARRATIVE: 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.

    Description of Event or Problem · 1

    ADDITIONAL REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION AND COMPONENT LOOSENING.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL - LEFT HIP; REASON 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, ALVAL / SOFT TISSUE REACTION AND COMPONENT LOOSENING - ACETABULAR COMPONENT. ENQUIRING INTO WHICH COMPONENT BECAME LOOSE. UPDATE: ADDED FURTHER REASON FOR REVISION ANS PRODUCT. RECEIVED: MARCH 28TH 2013. (B)(4). UPDATE: ADDED WHICH COMPONENT BECAME LOOSE. RECEIVED: APRIL 23RD 2013. UPDATE REC'D 15 APR 2014 - IMPLANT DATE, MARKED AS LEGAL. UPDATE RECEIVED: 15TH MAY 2014 - ADDED PATIENT NAME, ADDED PATIENT ID (INITIALS), ADDED PATIENT GENDER, ADDED PATIENT DATE OF BIRTH AND ADDED SURGEON TITLE.

    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, ALVAL / SOFT TISSUE REACTION AND COMPONENT LOOSENING - ACETABULAR COMPONENT. ENQUIRING INTO WHICH COMPONENT BECAME LOOSE. UPDATE: ADDED FURTHER REASON FOR REVISION ANS PRODUCT. RECEIVED: (B)(6) 2013. (B)(4). UPDATE: ADDED WHICH COMPONENT BECAME LOOSE. RECEIVED: (B)(6) 2013. UPDATE REC'D (B)(6) 2014 - IMPLANT DATE, MARKED AS LEGAL.

    Description of Event or Problem · 1

    ACETABULAR CUP LOOSENING NOT THE FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23211 DEPUY ASR XL FEM IMP SIZE 57 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL 2147321

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention