BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR TOTAL ACET IMPLANT SZ 54

    MDR report key: 2134054 · Received June 15, 2011

    Report

    Report Number
    1818910-2011-10213
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    March 10, 2011
    Report Date
    August 20, 2012
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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

    DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    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

    THE PT WAS REVISED TO ADDRESS OSTEOLYSIS AND HIGH METAL ION CONCENTRATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION ON THE ASR RIGHT HIP RESURFACING SYSTEM. THE REASON FOR THE REVISION WAS PAIN. THIS IS IN ADDITION TO THE PREVIOUSLY REPORTED CONDITIONS OF OSTEOLYSIS AND HIGH METAL ION CONCENTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR TOTAL ACET IMPLANT SZ 54 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 1839890

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention