BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM 11/13 STD 36+12 20X15X165

    MDR report key: 3094038 · Received May 6, 2013

    Report

    Report Number
    1818910-2013-05539
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    June 6, 2012
    Report Date
    October 22, 2025
    Manufacturer
    DEPUY IRELAND
    Product Code
    LZO
    PMA / PMN Number
    K961939
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    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).

    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

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION ON THE LEFT HIP IMPLANT. THE REASON FOR THE REVISION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196740 SROM 11/13 STD 36+12 20X15X165 HIP STEM LZO DEPUY IRELAND 1902660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention