BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 64

    MDR report key: 2871905 · Received December 13, 2012

    Report

    Report Number
    1818910-2012-25826
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    September 24, 2012
    Report Date
    March 7, 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
    US
    Reporter Occupation
    PATIENT

    Narratives

    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

    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. 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.

    Description of Event or Problem · 1

    REASON(S) FOR REVISION: PAIN, NOISE AND ALVAL.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL - LEFT; REASON FOR REVISION: PAIN.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER DINT 25938. REASON FOR ORIGINAL COMPLAINT - ASR REVISION, ASR XL - LEFT, REASON(S) FOR REVISION: PAIN. UPDATE - ADDED A STEM, REASON FOR REVISION AND PATIENT ID. TAKEN FROM FORM 73 DATED (B)(6) 2013. REASON FOR REVISION: NOISE AND ALVAL/ SOFT TISSUE DAMAGE. UPDATE RECEIVED (B)(6) 2014. SURGERY DATE AND REVISION DATE AMENDED.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER DINT 25938. REASON FOR ORIGINAL COMPLAINT: ASR REVISION, ASR XL - LEFT, REASON(S) FOR REVISION: PAIN. UPDATE - ADDED A STEM, REASON FOR REVISION AND PATIENT ID. TAKEN FROM FORM 73 DATED 25TH FEB 2013. REASON FOR REVISION: NOISE AND ALVAL/ SOFT TISSUE DAMAGE. UPDATE RECEIVED 22ND AND 26TH FEBRUARY, 2014. SURGERY DATE AND REVISION DATE AMENDED. UPDATE REC'D 7 MAR 2014 - MARKED AS LEGAL, ADDITIONAL HOSPITAL, IMPLANT DATE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR IMPLANT 64 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 2490683

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention