BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 3870915 · Received June 12, 2014

    Report

    Report Number
    1818910-2014-20927
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 27, 2014
    Report Date
    September 30, 2014
    Manufacturer
    DEPUY INTERNATIONAL 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
    TX, 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 (B)(4). DEPUY CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.(B)(4).DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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. (B)(4). DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED. (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.(B)(4). DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    UPDATE REC¿D 09/30/2014- PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION FROM PATIENT STICKER SHEET. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 10/16/2014.

    Description of Event or Problem · 1

    UPDATE REC'D 10/06/2014- LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 10/08/2014.

    Description of Event or Problem · 1

    UPDATE REC'D 9/4/2014 - MEDICAL RECORDS RECEIVED. PATIENT REVISED TO ADDRESS METALLOSIS. UPON REVISION, CORROSION MATERAL WAS NOTED ON THE FEMORAL NECK. THE STEM REMAINED IN SITU, AND A CERAMIC HEAD WAS IMPACTED ONTO THE STEM. THE SLEEVE IS BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: 09/23/2014.

    Description of Event or Problem · 1

    ASR REVISION REPORTED VIA SALES REP, LEFT. REASON(S) FOR REVISION : ELEVATED ION LEVELS. DER REFERENCES REMOVAL OF A 50MM ASR CUP, 45MM ASR HEAD AND A +0 SPACER HOWEVER NO PRODUCT/LOT NUMBERS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347412 ASR UNI FEMORAL IMPL SIZE 45 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD.-8010379 2050378

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention