BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ3 STD OFF

    MDR report key: 2243285 · Received September 12, 2011

    Report

    Report Number
    1818910-2011-17587
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    March 23, 2010
    Report Date
    February 20, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PP040023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. 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

    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

    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

    THE PATIENT WAS REVISED TO ADDRESS MICROMOTION.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR XL ACETABULAR SYSTEM - RIGHT HIP IMPLANTED (B)(6) 2009. REVISED DUE TO MICRO MOTION TO FEMORAL COMPONENT SO REMOVED AND ANOTHER PRIMARY CEMENTED STEM, FEMORAL IMPLANT & SLEEVE ADAPTOR WERE IMPLANTED LEAVING ACETABULAR CUP IN SITU. PATIENT FINE AFTER REVISION BUT NOW HAS HIGH COBALT LEVELS. UPDATE RECEIVED: 15TH OCTOBER 2013 - ADDED 47 REFERENCE NUMBER: (B)(4), AMENDED IMPLANT DATE: (B)(6) 2009, AMENDED REVISION DATE: (B)(6) 2010 AND CLARIFIED DETAILS. UPDATE - ADDITIONAL SURGEON , PATIENT INITIALS PATIENT GENDER, FILLED IN ALL MW FIELDS, ALL EXPIRY AND MANUFACTURING DATES. TAKEN FROM LEGAL LETTER DATED 20TH FEB 2015. PATIENT GENDER - FEMALE. PATIENT INITIALS - (B)(6). ADDITIONAL SURGEON - MR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT POR TAPER SZ3 STD OFF HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS, INC. C1VBY1000

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention