BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 56

    MDR report key: 3122161 · Received May 21, 2013

    Report

    Report Number
    1818910-2013-06072
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    March 12, 2012
    Report Date
    April 8, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL - LEFT HIP; REASON FOR REVISION: ALVAL/SOFT TISSUE REACTION.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) (B)(4). REASON FOR ORIGINAL COMPLAINT: ASR REVISION, ASR XL - LEFT, REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE RECEIVED: 8TH APRIL 2014 - ATTACHED LEGAL DOCUMENT, MARKED AS LEGAL, ADDED PATIENT NAME, ADDED PATIENT ID (INITIALS), ADDED PATIENT GENDER, ADDED PATIENT DATE OF BIRTH, AMENDED IMPLANT DATE: (B)(6) 2008, ADDED HOSPITALS: (B)(6), ADDED SURGEONS: MR (B)(6) / MR (B)(6) AND ADDED FURTHER REASON(S) FOR REVISION: PAIN, NOIS: CREAK AND SQUEAK, POPPING SENSATION, EXCESSIVE FLUID ON HIP, PSEUDOTUMOUR, SOFT TISSUE DESTRUCTION / NECROSIS DUE TO HIGH LOCAL CONCENTRATION OF METAL PARTICLES, FIELD DISTORTED BY NECROSIS AND DISCOLOURED GREY MECHANICAL FLUID: METALLOSIS AND DIFFICULTY WALKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224150 ASR ACETABULAR IMPLANT 56 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL LTD. 8010379 2453639

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention