BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 52

    MDR report key: 2162227 · Received July 7, 2011

    Report

    Report Number
    1818910-2011-12498
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    September 3, 2008
    Report Date
    April 3, 2013
    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

    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).

    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.

    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

    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 DINT (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ ASR REVISION. UPDATE: AMENDED REVISION DATE, ADDED SIDE HIP TO BE REVISED, PRODUCT TYPE, PRODUCTS AND REVISION REASON. RECEIVED: (B)(4) 2013. HIP(S) TO BE REVISED: RIGHT TYPE OF HIP REPLACEMENT PRODUCT: ASR XL REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION 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

    HIP(S) TO BE REVISED: RIGHT; TYPE OF HIP REPLACEMENT PRODUCT: ASR XL; REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION.

    Description of Event or Problem · 1

    THE PATIENT HAS HAD AN ASR REVISION. SPECIFIC DETAILS REGARDING THE REPORT ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR IMPLANT 52 87KWA KWA DEPUY INTERNATIONAL LTD. 8010379 NA 2415817

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention