BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 60

    MDR report key: 3183146 · Received June 21, 2013

    Report

    Report Number
    1818910-2013-19550
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    June 20, 2013
    Report Date
    September 15, 2014
    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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    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. 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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. ADDITIONAL NARRATIVE: 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

    ASR REVISION; ASR XL - RIGHT; REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION.

    Description of Event or Problem · 1

    REASON FOR REVISION: PAIN.

    Description of Event or Problem · 1

    ASR REVISION, ASR XL - RIGHT, REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION - INCORRECT SEE BELOW. UPDATE RECEIVED (B)(6) 2013. REVISION DATE AMENDED. STILL AWAITING CONFIRMATION OF REVISION DATE, HOWEVER IT MAY BE (B)(6) 2013. UPDATE FORM 57 RECEIVED (B)(6) 2013. ADDITIONAL HOSPITALS AND ADDITIONAL SURGEON ADDED. UPDATE RECEIVED (B)(6) 2013. REVISION DATE UPDATED, REASON FOR REVISION AMENDED. REASON(S) FOR REVISION: PAIN UPDATE RECEIVED: (B)(6) 2014 - FILLED MAPPED TO MW FIELDS, MARKED AS LEGAL, PUT CROSS REFERENCE IN COMPLAINT DESCRIPTION AND ADDED (B)(6) REFERENCE NUMBER. BILATERAL PATIENT - SEE COM (B)(4) FOR LEFT HIP. UPDATE - ATTACHED SCF, ADDED ADDITIONAL REASON FOR REVISION. TAKEN FROM SURGEON FORM DATED (B)(6) 2014. REASON(S) FOR REVISION : ALVAL / SOFT TISSUE REACTION / ELEVATED CO/CR ION LEVELS

    Description of Event or Problem · 1

    ASR REVISION; ASR XL - RIGHT. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE RECEIVED 4TH OCTOBER,2013. REVISION DATE AMENDED. STILL AWAITING CONFIRMATION OF REVISION DATE, HOWEVER, IT MAY BE (B)(6) 2013. UPDATE FORM (B)(4) RECEIVED 10TH OCTOBER, 2013. ADDITIONAL HOSPITALS AND ADDITIONAL SURGEON ADDED. UPDATE RECEIVED 11TH OCTOBER, 2013. REVISION DATE UPDATED, REASON FOR REVISION AMENDED. REASON(S) FOR REVISION: PAIN. UPDATE RECEIVED: 28TH MARCH 2014 - FILLED MAPPED TO MW FIELDS, MARKED AS LEGAL, PUT CROSS REFERENCE IN COMPLAINT DESCRIPTION AND ADDED (B)(4) REFERENCE NUMBER. BILATERAL PATIENT - SEE (B)(4) FOR LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282705 TOTAL ASR ACET IMP SIZE 60 TOTAL ASR ACET IMP SIZE 60 KWA DEPUY INTERNATIONAL LTD. 1811792

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention