BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 52

    MDR report key: 1983434 · Received January 31, 2011

    Report

    Report Number
    1818910-2011-01265
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    June 27, 2010
    Report Date
    August 27, 2014
    Manufacturer
    DEPUY INTERNATIONAL 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
    UNKNOWN

    Narratives

    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.

    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. 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. 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. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    Additional Manufacturer Narrative · 1

    THE REASON FOR REVISION WAS STATED AS INFECTION. THE INVESTIGATION FOUND THAT NO PRODUCT WAS RETURNED. THE PRIMARY SURGERY DATE WAS (B)(6) 2006 AND THE REVISION SURGERY DATE (B)(6) 2012. THE IMPLANTS WERE IMPLANTED FOR 6 YEARS AND 4 MONTHS. DUE TO THE LENGTH OF IMPLANTATION TIME IT IS NOT CONSIDERED THAT THE IMPLANTS WERE RESPONSIBLE FOR THE INFECTION. A REVIEW OF THE DHR (DEVICE HISTORY RECORD) FOR PRODUCT NUMBERS 999800102, 999804652, L20311 AND 999890146, LOT NUMBERS 2006980, 2019635, 2026266 AND 2072959 FOUND NO ANOMALIES. THE IRRADIATION CERTIFICATES SHOW THE DOSE TO BE WITHIN ALLOWABLE LIMITS AND NO OTHER ANOMALIES WERE FOUND. THE COMPLAINT SHALL BE CLOSED AS UNDETERMINED; NO PRODUCT PROBLEM IDENTIFIED. 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

    REVISED FOR PAIN.

    Description of Event or Problem · 1

    ASR REVISION.

    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, LEFT ASR XL ACETABULAR SYSTEM, REASON FOR REVISION: PAIN. UPDATE FROM (B)(6)'S (B)(6) 2011: DATE OF & REASON FOR REVISION, PRODUCTS, HOSPITAL, SURGEON. (B)(6) 2012 - UPDATE FROM (B)(6) SPREADSHEET DATED (B)(6) 2012 - CHANGED REVISION REASON AND SURGERY DATE, AND ADDED REVISION HOSPITAL. UPDATE FROM HOSPITAL REC'D (B)(6) 2013 - REASON FOR REVISION - CUP LOOSENING, COMPONENT MALALIGNMENT, NOISE, INFECTION (TESTED AND POSITIVE CULTURE CONFIRMED), METALLOSIS; SEX; DOB UPDATE: - (B)(6) 2014 - UPDATED DOI AND DOR TO (B)(6) RESPECTIVELY.

    Description of Event or Problem · 1

    NEW (B)(6) RECORD CREATED IN ORDER TO UPDATE (B)(6) (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION. LEFT ASR XL ACETABULAR SYSTEM. REASON FOR REVISION: PAIN. UPDATE FROM (B)(6) 18TH NOV 2011: DATE OF & REASON FOR REVISION, PRODUCTS, HOSPITAL, SURGEON. 26/1/12 - UPDATE FROM (B)(6) SPREADSHEET DATED 17 JANUARY 2012 - CHANGED REVISION REASON AND SURGERY DATE, AND ADDED REVISION HOSPITAL. UPDATE FROM HOSPITAL REC'D 1 NOV 2013 - REASON FOR REVISION - CUP LOOSENING, COMPONENT MALALIGNMENT, NOISE, INFECTION (TESTED AND POSITIVE CULTURE CONFIRMED), METALLOSIS; SEX; DOB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 52 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. NA 2026266

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention