BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABLAR IMPLANT 52

    MDR report key: 2013171 · Received February 24, 2011

    Report

    Report Number
    1818910-2011-02028
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    September 23, 2010
    Report Date
    February 5, 2012
    Manufacturer
    DEPUY INTERNATIONAL LTD.8010379
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510K# SUBMITTED AS DEPUY ORTHOPAEDICS SELLS A SIMILAR PRODUCT (OR THE SAME PRODUCT WITH A DIFFERENT PRODUCT CODE) IN THE US. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. 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.

    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, ASR XL ACETABULAR SYSTEM (RIGHT). HIP REVISED AND SYSTEM USED FROM (B)(4) DATED 06 FEB 2012. ADDITIONAL INFORMATION RECEIVED. ADDED REASON(S) FOR REVISION: ALVAL/SOFT TISSUE REACTION AND VERY HIGH ION LEVELS. THIS COMPLAINT WAS UPDATED ON JUL 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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED FOR UNKNOWN REASONS.

    Description of Event or Problem · 1

    ADDED REASON(S) FOR REVISION: ALVAL/ SOFT TISSUE REACTION.

    Description of Event or Problem · 1

    ASR REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABLAR IMPLANT 52 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD.8010379 NA 1812832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention