BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 3840018 · Received May 30, 2014

    Report

    Report Number
    1818910-2014-19774
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    DEPUY INTL., 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
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.(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. 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). DEPUY CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PAIN, WEAKNESS, SWELLING, STIFFNESS, AND ELEVATED METAL ION LEVELS.

    Description of Event or Problem · 1

    UPDATE 2/1/16 MEDICAL RECORDS RECEIVED. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. MEDICAL RECORDS CONTAINED PRIMARY AND REVISION SURGICAL OPERATIVE NOTES BUT NO COMPONENT STICKERS OR LIST. PRIMARY SURGERY NOTED A SUMMIT STEM IMPLANTED AND AN UNKNOWN SUMMIT STEM WILL BE REPORTED FOR THE ALLEGATION OF ELEVATED METAL ION LEVELS WITHOUT LAB RESULTS. THE REVISION SURGICAL NOTE REPORTED PATIENT REVISED FOR PAIN AND SURGEON HAD TROUBLE WITH ACETABULAR EXPLANT USING A COMPETITOR INSTRUMENT WITH EXCESS BONE REMOVED WITH COMPONENT AND BONE GRAFTING COMPLETED. COMORBIDITIES AND EXPIRATION DATES OF KNOWN PRODUCTS UPDATED. THE COMPLAINT WAS UPDATED ON: FEB 23, 2016

    Description of Event or Problem · 1

    LITIGATION ALLEGES PAIN, WEAKNESS, SWELLING, STIFFNESS, AND ELEVATED METAL ION LEVELS.UPDATE DER RECVD. UPDATED DOR, PATIENT AGE, SURGEON NAME, SALES REP DETAILS. UPDATED CUP AND HEAD. ADDED SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319577 ASR UNI FEMORAL IMPL SIZE 46 HIP FEMORAL HEAD KWA DEPUY INTL., LTD - 8010379 2712576

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R