BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ3 STD OFF

    MDR report key: 2234081 · Received September 6, 2011

    Report

    Report Number
    1818910-2011-17132
    Event Type
    Injury
    Date Received
    September 6, 2011
    Date of Event
    August 9, 2011
    Report Date
    January 19, 2013
    Manufacturer
    DEPUY WARSAW
    Product Code
    LPH
    PMA / PMN Number
    K001991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PATIENT

    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

    CORRECTED/UPDATED DATA: (EVENT DATE); (DATE OF REPORT); (EVENT DESCRIPTION); (IMPLANT DATE); (EXPLANT DATE); (NOT A REPROCESSED SINGLE USE DEVICE); (DATE RECEIVED BY MANUFACTURER); (LABELED FOR SINGLE USE). 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

    ASR REVISION; LEFT HIP; ASR XL ACETABULAR SYSTEM.

    Description of Event or Problem · 1

    ASR REVISION: LEFT ASR FEMORAL IMPLANT. REASON FOR REVISION: PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT POR TAPER SZ3 STD OFF HIP LPH DEPUY WARSAW Z3DE11000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention