BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 2213266 · Received August 12, 2011

    Report

    Report Number
    1818910-2011-14940
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    October 23, 2017
    Report Date
    January 26, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    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.

    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

    PLAINTIFFS PRELIMINARY DISCLOSURE (PPD) FORMS, IMPLANT STICKERS AND MEDICAL RECORDS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME.

    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. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: 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. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: 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. 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: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HIS RIGHT SIDE ON OR ABOUT (B)(6), 2006. PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HIS LEFT SIDE ON OR ABOUT (B)(6), 2007. PATIENT EXPERIENCED PAIN. PATIENT WILL BE HAVING THE LEFT ASR HIP EXPLANTED ON OR ABOUT (B)(6) 2011, BUT HAS NOT YET SCHEDULED AN EXPLANTATION OF THE RIGHT ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE REC¿D (B)(6) 2015 - MEDICAL RECORDS RECEIVED FOR LEFT HIP REVISION. MEDICAL RECORDS REPORT ELEVATED METAL ION LEVELS. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: (B)(6) 2015.

    Description of Event or Problem · 1

    AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN AND ADVERSE LOCAL TISSUES REACTION. HIS PREOPERATIVE COBALT LEVEL WAS 45.6, NO UNIT PROVIDED. RADIOGRAPHS SHOWED, THERE WERE CONSISTENT ADVERSE LOCAL TISSUE REACTION RESULTING IN HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 56 ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL LTD - 8010379 NA 2036221

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention ADAPTER SLEEVES 12/14 +8| ASR UNI FEMORAL IMPL SIZE 49| SUMMIT POR TAPER SZ5 HI OFF