BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 43

    MDR report key: 2240571 · Received September 9, 2011

    Report

    Report Number
    1818910-2011-17704
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    May 17, 2016
    Report Date
    August 11, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

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

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # :(B)(4). INVESTIGATION SUMMARY: THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN. THE INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS WAS CONDUCTED UNDER MDD CAPA-)(B)(4). ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE ON OR ABOUT (B)(6), 2010, PATIENT SUFFERED ACHES AND PAIN IN HER LEFT HIP, PAIN WHEN LYING ON HER LEFT SIDE, STIFFNESS AND DIFFICULTY WITH ACTIVITIES OF DAILY LIVING. IT IS FURTHER ALLEGED PATIENT COULD NOT HAVE KNOWN THAT SHE WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT UNTIL AFTER THE DATE SHE HAD BLOOD DRAWN AND WAS ADVISED OF THE RESULTS OF SAID BLOOD WORK. PATIENT HAS NOT YET SCHEDULED AN EXPLANTATION OF THE ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE: APR 24, 2017: LEGAL MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS REPORTED THAT THE PATIENT HAD A REVISION ON (B)(6) 2016 ON LEFT HIP. THE SLEEVE AND STEM WERE ADDED TO THE COMPLAINT FOR ALLEGED EXCESSIVE LEVELS OF COBALT AND CHROMIUM. THIS COMPLAINT WAS UPDATED ON APR 27, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 43 FEMORAL HEAD KWA DEPUY ORTHOPAEDICS INC US 2178020

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention