BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 47

    MDR report key: 3526637 · Received December 18, 2013

    Report

    Report Number
    1818910-2013-36531
    Event Type
    Injury
    Date Received
    December 18, 2013
    Date of Event
    December 18, 2013
    Report Date
    March 11, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KXA
    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

    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. 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.

    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.

    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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ ASR REVISION RECOMMENDED. ASR XL - LEFT. REASON(S) FOR REVISION: INFECTION (TESTED AND POSITIVE CULTURE CONFIRMED). UPDATE: ADDED REVISION DATE. RECEIVED: (B)(6) 2013. BILATERAL PATIENT FOR RIGHT HIP SEE (B)(4). UPDATE - RECEIVED (B)(6) 2013 - AMENDMENT TO IMPLANT DATE. UPDATE RECEIVED: (B)(6) 2013 - AMENDED IMPLANT DATE: (B)(6) 2007, AMENDED REVISION DATE: (B)(6) 2011, CROSS REFERENCED AND ADDED FURTHER REVISION REASONS: ALVAL / SOFT TISSUE REACTION AND METALLOSIS. UPDATE RECEIVED: (B)(6) 2013 - ADDED PATIENT DETAILS: NAME AND DATE OF BIRTH AND ATTACHED OPERATION RECORD.

    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 RECOMMENDED, ASR XL - LEFT, REASON(S) FOR REVISION: INFECTION (TESTED AND POSITIVE CULTURE CONFIRMED). UPDATE: ADDED REVISION DATE. RECEIVED: (B)(6) 2013. BILATERAL PATIENT FOR RIGHT HIP SEE COM 033223 / DINT 26736 UPDATE - RECEIVED (B)(6) 2013 - AMENDMENT TO IMPLANT DATE. UPDATE RECEIVED: (B)(6) 2013 - AMENDED IMPLANT DATE: (B)(6) 2007, AMENDED REVISION DATE: (B)(6) 2011, CROSS REFERENCED AND ADDED FURTHER REVISION REASONS: ALVAL / SOFT TISSUE REACTION AND METALLOSIS. UPDATE RECEIVED: (B)(6) 2013 - ADDED PATIENT DETAILS: NAME AND DATE OF BIRTH AND ATTACHED OPERATION RECORD. UPDATE (B)(6) 2015 - REC'D CLAIMSUITE AND CONFIRMATION OF DETAILS FROM FILE HANDLER. ADDED DUMMY STEM AS CASE IS XL BUT NO STEM DETAILS ARE AVAILABLE. CORRECTED IMPLANT DATE. ADDED EXP/MAN DATES FOR ALL KNOWN PRODUCTS. FILLED IN ALL MW FIELDS. FILE HANDLER CLAIMS THAT THE ONLY REASON FOR REVISION WAS INFECTION. I HAVE QUERIED WHETHER THIS IS TRUE WITH THE FILE HANDLER. IF SO, I WILL REQUEST PATIENT DEMOS. I HAVE ALSO HAD TO REQUEST FURTHER DETAILS OF 2ND REVISION AS PATIENT WAS REVISED AGAIN ON (B)(6) 2011 AS PART OF A TWO STAGE REVISION. UPDATE (B)(6) 2015: TEMPORARY SPACERS WERE INSERTED AT STAGE 1 RIGHT ((B)(6) 2012) AND STAGE 1 LEFT ((B)(6) 2011). ALL ASR PRODUCTS WERE REMOVED. THE LEFT HIP STAGE 1 OP REPORT CONFIRMS SMALL AMOUNT OF METALLOSIS PRESENT. THE SURGEON HAS STATED THAT INVESTIGATIONS PRE OP SHOWED ELEVATED COBALT LEVELS PLUS SIGNS OF INFECTION. ADDED INCREASED METAL IONS. CLOSED REQUEST.

    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 RECOMMENDED. ASR XL - LEFT, REASON(S) FOR REVISION: INFECTION (TESTED AND POSITIVE CULTURE CONFIRMED). UPDATE: ADDED REVISION DATE. RECEIVED: FEBRUARY 13TH 2013. BILATERAL PATIENT FOR RIGHT HIP (B)(4). UPDATE - RECEIVED 20 MARCH 2013 - AMENDMENT TO IMPLANT DATE. UPDATE RECEIVED: 12TH DECEMBER 2013 - AMENDED IMPLANT DATE: (B)(6) 2007, AMENDED REVISION DATE: (B)(6) 2011, CROSS REFERENCED AND ADDED FURTHER REVISION REASONS: ALVAL / SOFT TISSUE REACTION AND METALLOSIS. UPDATE RECEIVED: 18TH DECEMBER 2013 - ADDED PATIENT DETAILS: NAME AND DATE OF BIRTH AND ATTACHED OPERATION RECORD. UPDATE 24 FEB 2015 - REC'D CLAIMSUITE AND CONFIRMATION OF DETAILS FROM FILE HANDLER. ADDED DUMMY STEM AS CASE IS XL BUT NO STEM DETAILS ARE AVAILABLE. CORRECTED IMPLANT DATE. ADDED EXP/MAN DATES FOR ALL KNOWN PRODUCTS. FILLED IN ALL MW FIELDS. FILE HANDLER CLAIMS THAT THE ONLY REASON FOR REVISION WAS INFECTION. I HAVE QUERIED WHETHER THIS IS TRUE WITH THE FILE HANDLER. IF SO, I WILL REQUEST PATIENT DEMOS. I HAVE ALSO HAD TO REQUEST FURTHER DETAILS OF 2ND REVISION AS PATIENT WAS REVISED AGAIN ON (B)(6) 2011 AS PART OF A TWO STAGE REVISION. UPDATE 3 MAR 2015: TEMPORARY SPACERS WERE INSERTED AT STAGE 1 RIGHT ((B)(6) 2012) AND STAGE 1 LEFT ((B)(6) 2011). ALL ASR PRODUCTS WERE REMOVED. THE LEFT HIP STAGE 1 OP REPORT CONFIRMS SMALL AMOUNT OF METALLOSIS PRESENT. THE SURGEON HAS STATED THAT INVESTIGATIONS PRE OP SHOWED ELEVATED COBALT LEVELS PLUS SIGNS OF INFECTION. ADDED INCREASED METAL IONS. CLOSED REQUEST. UPDATE 11 MAR 2015: ADDED PATIENT'S SEX PREVIOUSLY MISSED. SM 11 MAR 2015

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660819 DEPUY ASR XL FEM IMP SIZE 47 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 2223697

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention