BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 56

    MDR report key: 2232836 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-13700
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    February 19, 2014
    Report Date
    March 25, 2014
    Manufacturer
    DEPUY INTL, LTD
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IMPLANT IS NOT SOLD IN THE U.S. TO BE IMPLANTED FOR THIS INDICATION; IT WOULD BE SOLD UNDER A DIFFERENT PART NUMBER SINCE IT IS ONLY INDICATED TO BE USED AS A HEMI IN THE U.S. AT THIS TIME. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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. THIS IMPLANT IS NOT SOLD IN THE US TO BE IMPLANTED FOR THIS INDICATION; IT WOULD BE SOLD UNDER A DIFFERENT PART NUMBER SINCE IT IS ONLY INDICATED TO BE USED AS A HEMI IN THE US AT THIS TIME. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    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. THIS IMPLANT HAS NOT YET BEEN REVISED. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. 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.

    Description of Event or Problem · 1

    REVISED FOR 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; ASR XL ACETABULAR SYSTEM (LEFT); ASR XL ACETABULAR SYSTEM (RIGHT). (B)(4) - ADDED REVISION REASON AND HOSPITAL. UPDATE RECEIVED (B)(4) 2014. REVISION DATE, SURGERY DATE, PRODUCTS AND REASONS FOR REVISION QUERIED. REPLY TO QUERY OF (B)(4) 2014 RECEIVED (B)(4) 2014. HIP SIDES CONFIRMED FOR PRODUCTS. REASONS FOR REVISION, REVISION AND SURGERY DATES CONFIRMED. STEM ADDED FOR RIGHT HIP. LEFT HIP INFORMATION: 999800108 / 2585489; 999804956 / 2658057; 999890149 / 2715614. IMPLANT DATE: (B)(6) 2008. REVISION DATE: (B)(6) 2011. REASON FOR REVISION: PAIN. RIGHT HIP INFORMATION: 999800105 / 2533287; 999804956 / 2397441; 999890149 / 2460896; L20311 / 2317064. IMPLANT DATE: (B)(6) 2008. REVISION DATE: TO TAKE PLACE ON (B)(6) 2014. REASON FOR REVISION: PAIN, METALLOSIS, ALVAL / SOFT TISSUE REACTION.

    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 ACETABULAR SYSTEM (LEFT); ASR XL ACETABULAR SYSTEM (RIGHT). 6/1 - UPDATE FROM (B)(6) SPREADSHEET DATED 21 DECEMBER 2011- ADDED REVISION REASON AND HOSPITAL. UPDATE RECEIVED 22ND JANUARY, 2014. REVISION DATE, SURGERY DATE, PRODUCTS AND REASONS FOR REVISION QUERIED. REPLY TO QUERY OF 22ND JANUARY, 2014 RECEIVED 29TH JANUARY, 2014. HIP SIDES CONFIRMED FOR PRODUCTS. REASONS FOR REVISION, REVISION AND SURGERY DATES CONFIRMED. STEM ADDED FOR RIGHT HIP. LEFT HIP INFORMATION: 999800108 / 2585489, 999804956 / 2658057, 999890149 / 2715614. IMPLANT DATE: (B)(6) 2008, REVISION DATE: (B)(6) 2011, REASON FOR REVISION: PAIN. RIGHT HIP INFORMATION: 999800105 / 2533287, 999804956 / 2397441, 999890149 / 2460896, L20311 / 2317064. IMPLANT DATE: (B)(6) 2008, REVISION DATE: TO TAKE PLACE ON (B)(6) 2014, REASON FOR REVISION: PAIN, METALOSIS, ALVAL / SOFT TISSUE REACTION. UPDATE -ENTERED MANUFACTURING DATES, RECEIVED CONFIRMATION THAT REVISION HAS TAKEN PLACE. TAKEN FROM (B)(6) SPREADSHEET DATED 25TH MARCH 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 56 HIP ACETABULAR CUP KWA DEPUY INTL, LTD NA 2397441

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention