BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR FEM IMPLANT SZ 45

    MDR report key: 2980684 · Received February 27, 2013

    Report

    Report Number
    1818910-2013-02919
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    February 21, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KXA
    PMA / PMN Number
    PK032659
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. REF. (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

    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. REF. (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

    THIS REPORT IS STILL CONSIDERED 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

    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.

    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.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN, WEAKNESS AND DIFFICULTY WITH SIMPLE DAILY ACTIVITIES AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE 10/16/2015 - MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE MEDICAL RECORDS INDICATED THAT THE PATIENT HAD AN ASR HIP RESURFACING PLACED ON (B)(6) 2007. THE REVISION OPERATIVE NOTE FROM (B)(6) 2015 INDICATED METALLOSIS AND ELEVATED METAL IONS. THE PREVIOUSLY REPORTED UNKNOWN ASR SLEEVE AND STEM ARE BEING REJECTED AS THEY WERE NEVER IMPLANTED ON (B)(6) 2007. THE COMPLAINT WAS UPDATED ON: 11/5/2015.

    Description of Event or Problem · 1

    UPDATE REC'D 12/10/2015- LITIGATION RECEIVED. PART/LOT WAS UPDATED FOR THE HEAD AND CUP. THE COMPLAINT WAS UPDATED ON DEC 18, 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84259 DEPUY ASR FEM IMPLANT SZ 45 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL 2322209

    Patients

    Seq Age Sex Outcome Treatment
    1 Other