BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR 300 SPIKED CUP SIZE 54

    MDR report key: 2230326 · Received September 1, 2011

    Report

    Report Number
    1818910-2011-17030
    Event Type
    Injury
    Date Received
    September 1, 2011
    Report Date
    November 16, 2016
    Manufacturer
    DEPUY INTERNATIONAL LTD.8010379
    Product Code
    KWA
    PMA / PMN Number
    K073443
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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

    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, 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

    CORRECTED/ADDED: PATIENT IDENTIFIER, ALERT DATE, DESCRIBE EVENT OR PROBLEM, RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES, OTHER RELEVANT HISTORY, COMMON DEVICE NAME/DEVICE PRODUCT CODE, REPORT SOURCE, DATE RECEIVED BY MFG., PATIENT CODE/DEVICE CODE. 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

    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. 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

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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 THE PATIENT IS EXPERIENCING SEVERE PAIN IN THE RIGHT HIP RADIATING INTO THE RIGHT LOWER EXTREMITY, MAKING IT DIFFICULT AND PAINFUL FOR HIM TO WALK OR PERFORM ANY PHYSICAL ACTIVITY. HE ALSO SUFFERS FROM WEAKNESS AND NUMBNESS AND TINGLING IN THE RIGHT LOWER EXTREMITY. IT IS FURTHER ALLEGED HE HAS BEEN INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT.

    Description of Event or Problem · 1

    UPDATE 11/16/2016 ¿MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED MEDICAL RECORDS FROM (B)(6) 2015 REPORT THAT THE PATIENT HAD A FALL CAUSING INJURY TO BACK AND RIGHT HIP. THE METAL ION LEVELS PROVIDED WERE AT REPORTABLE LEVELS. THERE WAS AN ATTEMPTED REVISION ON (B)(6) 2016 TO ADDRESS PAIN AND ELEVATED METAL ION LEVELS. THE SURGEON EXCISED PERIACETABULAR HETEROTOPIC BONE. WHILE APPLYING TRACTION TO THE PATIENT, THE TIBIA FRACTURED. THE COMPONENTS WERE LEFT IN PLACE AND THE PATIENT THEN HAD A CLOSED REDUCTION AND INTERNAL FIXATION OF RIGHT MID-SHAFT MINIMALLY DISPLACED SPIRAL OBLIQUE FRACTURE OF THE RIGHT TIBIA. ADDING STEM AND ASR SLEEVE DUE TO ELEVATED ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR 300 SPIKED CUP SIZE 54 ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL LTD.8010379 ?2771831

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention