BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 54

    MDR report key: 3023426 · Received March 27, 2013

    Report

    Report Number
    1818910-2013-04501
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    October 17, 2011
    Report Date
    March 17, 2013
    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. (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.

    Additional Manufacturer Narrative · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGAL SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT, ASR REVISION TO TAKE PLACE (B)(6)2012, ASR XL ACETABULAR SYSTEM (LEFT) ALTHOUGH THE CLAIM E-MAIL SAYS BI-LATERAL, ONLY ONE SET OF PRODUCTS WAS LISTED. CONFIRMATION HAS BEEN RECEIVED THAT ONLY THE LEFT HIP WAS AN ASR AND HAS BEEN REVISED AND NEW SURGERY DATES RECEIVED. UPDATE: DATE OF REVISION FROM CRAWFORDS EMAIL RECEIVED 14 DEC 2011. THIS DINT IS FOR THE LEFT HIP REVISION. FOR THE RIGHT HIP REVISION PLEASE SEE (B)(4). UPDATE: ADDED REVISION DATE AND REASON FOR REVISION. RECEIVED: MARCH 18TH 2013. REASON(S) FOR REVISION: PAIN. 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 ACETABULAR SYSTEM (LEFT); REASON(S) FOR REVISION: PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126751 ASR ACETABULAR IMPLANT 54 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 1839887

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention