BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 52

    MDR report key: 2162215 · Received July 7, 2011

    Report

    Report Number
    1818910-2011-12126
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    July 1, 2009
    Report Date
    March 7, 2014
    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

    1818910-2009-03814 IS A DUPLICATE REPORT OF 1818910-2011-12126. 1818910-2009-03814 WILL BE REJECTED.1818910-2011-12126 WILL BE KEPT FOR INVESTIGATION PURPOSES.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

    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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION: ASR XL ACETABULAR SYSTEM (RIGHT). REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE REC'D (B)(6) 2014 - SURGERY DATE; ADDITIONAL PRODUCTS. AFTER INVESTIGATION WE FOUND (B)(6) HAD A DUPLICATE - (B)(4). AS A RESULT (B)(4) WAS (B)(4) RECREATED AS A (B)(4) AND SUBSEQUENTLY VOIDED. ALL ATTACHMENTS AND INFORMATION FROM (B)(4) HAS BEEN ADDED TO THIS COM.

    Description of Event or Problem · 1

    THE PT WAS REVISED TO ADDRESS ALVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR IMPLANT 52 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 NA 2435434

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention