BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 47

    MDR report key: 2943686 · Received February 5, 2013

    Report

    Report Number
    1818910-2013-01593
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 21, 2013
    Report Date
    July 24, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    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

    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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    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; REASON(S) FOR REVISION: 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 - LEFT. REASON(S) FOR REVISION: PAIN. BI-LATERAL - PLEASE SEE (B)(4) FOR RIGHT SIDE REVISION. NO LOT NUMBER PROVIDED FOR HEAD. UPDATE RECEIVED 5TH JULY 2014. QUERY RESPONSE INFORMATION RECEIVED 10TH JULY. LOT NUMBER ADDED TO FEMORAL HEAD. SURGERY DATE AMENDED. PRODUCT (B)(4) WAS INSERTED IN ERROR AND HAS NOT BEEN TRANSFERRED ONTO THE COM SYSTEM. CORRECT CODE IS (B)(4)AND BELONGS TO THE FEMORAL HEAD.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER DINT (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION. ASR XL - LEFT. REASON(S) FOR REVISION: PAIN. BI-LATERAL - PLEASE SEE (B)(4) FOR RIGHT SIDE REVISION. NO LOT NUMBER PROVIDED FOR HEAD. UPDATE RECEIVED 5TH JULY 2014. QUERY RESPONSE INFORMATION RECEIVED 10TH JULY. LOT NUMBER ADDED TO FEMORAL HEAD. SURGERY DATE AMENDED. PRODUCT 960043 / 2989529 (SEE DINT) WAS INSERTED IN ERROR AND HAS NOT BEEN TRANSFERRED ONTO THE COM SYSTEM. CORRECT CODE IS 2969529 AND BELONGS TO THE FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48233 DEPUY ASR XL FEM IMP SIZE 47 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 2969529

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention