BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR FEMORAL HEAD

    MDR report key: 3052448 · Received April 11, 2013

    Report

    Report Number
    1818910-2013-04720
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    November 15, 2012
    Report Date
    July 17, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    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. 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. MFR 1818910 - 2013 - 04720 WAS REPORTED IN ERROR AND IS BEING REJECTED.

    Description of Event or Problem · 1

    ASR REVISION; ASR RESURFACING - LEFT HIP; REASON FOR REVISION: ALVAL/SOFT TISSUE REACTION.

    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 RESURFACING - LEFT. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. PLEASE NOTE ONLY HEAD REVISED AS CUP REMAINED IN SITU. PLEASE NOTE PRODUCTS AND REVISION DATES ARE STILL BEING QUERIED. THIS IS THE FIRST OF 2 REVISIONS - PLEASE SEE (B)(4 OR 2ND LEFT REVISION. BI-LATERAL PATIENT - PLEASE SEE (B)(4) FOR 1ST RIGHT SIDE - SECOND RIGHT SIDE REVISION YET TO TAKE PLACE. RE-CREATED 17TH JULY 2014 TO VOID AS THIS PATIENT HAS FOUND TO HAVE AN XL REVISION ONLY AND NOT A RESURFACING REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154284 UNKNOWN DEPUY ASR FEMORAL HEAD ASR TOTAL HIP REPLACEMENT KXA DEPUY INTERNATIONAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention