BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 41

    MDR report key: 2231657 · Received September 1, 2011

    Report

    Report Number
    1818910-2011-17119
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    December 5, 2017
    Report Date
    August 4, 2011
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    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

    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

    (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

    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).

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT SUFFERED INJUR(IES) INCLUDING BUT NOT LIMITED TO GRINDING, METAL FLAKES IN AND AROUND THE SOCKET, FLUID, PAIN, SWELLING, LIMITED RANGE OF MOTION. IT IS FURTHER ALLEGED PATIENT COULD NOT HAVE KNOWN THAT HE/SHE WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT UNTIL AFTER THE DATE HE/SHE HAD HIS/HER BLOOD DRAWN AND HE/SHE 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

    DER RECEIVED. THE PATIENT WAS REVISED TO ADDRESS MALPOSITIONED ACETABULUM AND CUP WAS VERY LOOSE IN BONE TO IMPLANT INTERFACE. IT WAS STATED THAT THE PATIENT WAS BROUGHT TO OR TO HAVE AN I&D AND REVISE HER LEFT HIP IN SINGLE STAGE. THIS PATIENT HAD A LEFT PRIMARY #2 STD TRILOCK STEM WITH A 46MM/300 ASR ACETABULUM CUP, A 41MM ASR HEAD AND ADAPTOR IMPLANTED ELSEWHERE ON AN UNKNOWN DATE. MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN, DYSFUNCTION, ACETABULAR LOOSENING AND METALLOSIS. REVISION NOTES REPORTED AN ALMOND LIKE FLUID IN THE JOINT CONSISTENT WITH METALLOSIS AND BONE LOSS. THE TISSUES DID NOT APPEAR INFLAMED IN A WAY CONSISTENT WITH INFECTION. THERE WAS A 1 CM LATERAL CORTICAL DEFECT PRESENT. THE ACETABULAR COMPONENT WAS LOOSE. DUE TO NO GROSS EVIDENCE OF INFECTION AND THE POSSIBLE EXPLANATION FOR THE ELEVATED WBC IN THE JOINT TAP, A ONE STAGE REVISION WAS NECESSARY. INDICATIONS FOR PROCEDURE REPORTED, THE PATIENTS COBALT WAS VERY ELEVATED. THE SOCKET WAS LOOSE AND MIGRATED VERTICAL. THE CRP LEVEL IS NORMAL BUT ESR WAS MILDLY ELEVATED. THERE WERE NO LABORATORY VALUES PROVIDED. ADDED STEM AND SLEEVE SINCE THEY WERE REVISED. DOI: (B)(6) 2009 : DOR: (B)(6) 2017 (LEFT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 41 HIP KWA DEPUY INTERNATIONAL LTD. 8010379 2746948

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention