BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 49

    MDR report key: 3070787 · Received April 22, 2013

    Report

    Report Number
    1818910-2013-04961
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 10, 2013
    Report Date
    August 8, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD8010379
    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

    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. 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.

    Additional Manufacturer Narrative · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER DINT 26588. REASON FOR ORIGINAL COMPLAINT ¿ ASR REVISION DUE TO TAKE PLACE (B)(6) 2013 ASR XL - RIGHT REASON(S) FOR REVISION: PAIN AND ELEVATED CHROME AND COBALT LEVELS. SOUTH AFRICA REFERENCE NUMBER: FNOL-DEP-JJ-05682 UPDATE - AMENDED ORIGINAL SURGERY DATE TAKEN FROM CLAIMSUITE DATED (B)(6) 2013 ***UPDATE RECEIVED AUGUST 8TH, 2013. SURGERY DATE AMENDED*** UPDATE NOV 17, 2017: EMAIL NOTIFICATION RECEIVED. THERE IS NO NEW INFORMATION ADDED THAT CHANGES THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON: NOV 21, 2017. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER DINT 26588. REASON FOR ORIGINAL COMPLAINT ¿ ASR REVISION DUE TO TAKE PLACE (B)(6) 2013 ASR XL - RIGHT REASON(S) FOR REVISION: PAIN AND ELEVATED CHROME AND COBALT LEVELS. SOUTH AFRICA REFERENCE NUMBER: FNOL-DEP-JJ-05682 UPDATE - AMENDED ORIGINAL SURGERY DATE TAKEN FROM CLAIMSUITE DATED 12TH APRIL 2013 ***UPDATE RECEIVED AUGUST 8TH, 2013. SURGERY DATE AMENDED*** UPDATE NOV 17, 2017: EMAIL NOTIFICATION RECEIVED. THERE IS NO NEW INFORMATION ADDED THAT CHANGES THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON: NOV 21, 2017. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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: PAIN AND ELEVATED CHROME AND COBALT LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171203 DEPUY ASR XL FEM IMP SIZE 49 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL LTD8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention