BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 46

    MDR report key: 11975180 · Received June 10, 2021

    Report

    Report Number
    1818910-2021-12350
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    May 26, 2021
    Report Date
    May 27, 2021
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: THIS HIP REPLACEMENT PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET AND THE PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: PREVIOUS INVESTIGATIONS THAT HAVE INCLUDED DEVICE HISTORY REVIEWS SINCE THE ASR PLATFORM WAS LAUNCHED HAVE SHOWN NO INDICATION OF DEVIATIONS OR ANOMALIES WITH REGARD TO MATERIAL, MANUFACTURING, OR INSPECTION. THEREFORE, NO DEVICE HISTORY RECORD (DHR) REVIEW FOR THIS INDIVIDUAL ASR COMPONENT WILL BE CARRIED OUT AT THIS POINT IN TIME.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. 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

    ASR XL CLAIMSUITE ALERTS RECEIVED. REASON FOR REVISION: PAIN. PATIENT HAS SIGNIFICANT BONE LOSS AND LOOSENING OF ACETABULAR IMPLANT. PATIENT HAS PAIN SIGNIFICANTLY INCREASED FOR LAST 3 MONTHS. CURRENT CT/NRI ALL SHOW SIGNIFICANT OSTEOLYSIS AND LOOSENING OF ACETABULAR COMPONENT. THIS PATIENT WILL REQUIRE REVISION OF THR AS SOON AS POSSIBLE WITH AUGMENTATION PROCEDURE FOR ACETABULAR OSTEOLYSIS. DOI: (B)(6) 2007 DOR: (B)(6) 2021 LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874343 ASR ACETABULAR IMPLANT 46 ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS KWA DEPUY INTERNATIONAL LTD - 8010379 1839873

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ASR ACETABULAR IMPLANT 46.| DEPUY ASR XL FEM IMP SIZE 41.| LARGE MOD HEAD ADAPT 12/14 +5.| SUMMIT POR TAPER SZ1 STD OFF.| ASR ACETABULAR IMPLANT 46| DEPUY ASR XL FEM IMP SIZE 41| LARGE MOD HEAD ADAPT 12/14 +5| SUMMIT POR TAPER SZ1 STD OFF