BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 60

    MDR report key: 3013238 · Received March 20, 2013

    Report

    Report Number
    1818910-2013-03616
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    March 8, 2012
    Report Date
    April 14, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    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 THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    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; ASR XL - LEFT HIP; REASON FOR REVISION: COMPONENT LOOSENING.

    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, ASR XL - LEFT, REASON(S) FOR REVISION: COMPONENT LOOSENING (CUP). UPDATE: REASON FOR REVISION AND PRODUCT DETAILS RECEIVED (B)(6) 2013. UPDATE - ADDED ADDITIONAL HOSPITAL AND AMENDED SURGERY AND REVISION DATES TAKEN FROM (B)(6) EMAIL DATED (B)(6) 2013. UPDATE 14 APR 2015 - QUERIED SURGERY DATE AND LOT NUMBERS - RESPONSE RECEIVED - FURTHER TO YOUR EMAIL BELOW, I CAN CONFIRM THAT THE PRIMARY SURGERY WAS PERFORMED ON THE (B)(6) 2005 AND THE REVISION SURGERY ON THE (B)(6) 2013 AS CONFIRMED BY THE SURGEON CONFIRMATION FORM AND OPERATION NOTES. HEAD LOT NUMBER: 1652471. STEM LOT NUMBER: 1852889. THE HEAD LOT IS NOT IN (B)(4), LEFT AS IS. UPDATED SURGERY DATE - ADDED ALL MAPPED TO MW FIELDS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115861 TOTAL ASR ACET IMP SIZE 60 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 1915233

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention