BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPER SLEEVE ADAPTER 12/14 +8

    MDR report key: 3120459 · Received May 20, 2013

    Report

    Report Number
    1818910-2013-06051
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    July 5, 2009
    Report Date
    July 2, 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
    UK
    Reporter Occupation
    ATTORNEY

    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. (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

    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 - RIGHT HIP; REASON FOR REVISION: UNKNOWN.

    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 - RIGHT, INCORRECT SEE BELOW. REASON(S) FOR REVISION: UNKNOWN. (B)(6). BI-LATERAL PATIENT, PLEASE SEE (B)(4) FOR THE LEFT SIDE REVISION. SURGEON CONFIRMATION FORM RECEIVED 2ND JULY 2014. HIP SIDE, REVISION DATE, SURGERY DATE, TAPER SLEEVE AMENDED. REVISION REASON ADDED. HIP(S) TO BE REVISED: LEFT. REASON(S) FOR REVISION: ALVAL/SOFT TISSUE REACTION. BI-LATERAL PATIENT, PLEASE SEE (B)(4) FOR THE RIGHT SIDE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222480 TAPER SLEEVE ADAPTER 12/14 +8 HIP FEMORAL STEM/SLEEVE KWA DEPUY INTERNATIONAL LTD. 8010379 2071796

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention