BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 3163669 · Received June 11, 2013

    Report

    Report Number
    1818910-2013-18643
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    June 3, 2013
    Report Date
    July 2, 2013
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORT OF 1818910-2012-71887. THIS REPORT, 1818910-2013-18643 WILL BE KEPT FOR INVESTIGATION PURPOSES. 1818910-2012-71887 IS BEING REJECTED. DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT REVISION DUE TO UNKNOWN REASON.

    Description of Event or Problem · 1

    **UPDATE** - MEDICAL RECORDS RECEIVED (B)(4) 2013. REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: CAPSULE WAS EXTREMELY THICKEND AND FIBROTIC; HIP APPEARED TO HAVE ABUNDANT FIBROUS TISSUE PRESENT WITHIN THE CAPSULE ITSELF; EXCESSIVE FIBROUS DEBRIS; DISCOLORATION OF THE SYNOVIUM CONSISTENT WITH A MILD METALLOSIS; GRAYISH-TYPE TISSUE REMOVED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264282 ASR ACETABULAR CUPS 50 ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2079022

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention