BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 9288707 · Received November 6, 2019

    Report

    Report Number
    1818910-2019-111004
    Event Type
    Injury
    Date Received
    November 6, 2019
    Date of Event
    March 12, 2010
    Report Date
    October 14, 2019
    Manufacturer
    DEPUY INT'L LTD. 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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-001226. ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT. 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 DHR (DEVICE HISTORY RECORD) REVIEW FOR THIS INDIVIDUAL ASR COMPONENT WILL BE CARRIED OUT AT THIS POINT IN TIME. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. THE INVESTIGATION TO DETERMINE ROOT CAUSE WAS CONDUCTED UNDER MDD CAPA-001226. ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT. DEVICE HISTORY LOT : NULL. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL.

    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. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    "LITERATURE ARTICLE ENTITLED, ¿THE RELATIONSHIP BETWEEN THE PRESENCE OF METALLOSIS AND MASSIVE INFECTION IN METAL-ON-METAL HIP REPLACEMENTS¿ BY JAMES R. DONALDSON, ET AL, PUBLISHED BY HIP INTERNATIONAL (2010), VOL. 20, NO. 02, PP. 242-247, WAS REVIEWED. THE AUTHORS PRESENT A SMALL SERIES OF A PREVIOUSLY UNREPORTED COMPLICATION, WHICH APPEARS SPECIFIC TO METAL-ON-METAL BEARING SURFACE ARTHROPLASTIES: THREE CASES OF INFECTION IN THE PRESENCE OF LOCAL METAL DEBRIS AND HISTOLOGICAL FEATURES OF ASEPTIC LYMPHOCYTIC VASCULITIS ASSOCIATED LESIONS (ALVAL). EACH CASE IS ASSOCIATED WITH SIGNIFICANT SOFT TISSUE LOSS AND BONE DESTRUCTION TO SUCH AN EXTENT THAT PELVIC DISCONTINUITY HAS OCCURRED. TWO OF THE CASES PRESENTED WERE IMPLANTED WITH COMPETITOR PRODUCTS AND ARE NOT INCLUDED IN THIS COMPLAINT. CASE 2, WITH AN ASR-XL SYSTEM AND CORAIL STEM IS CAPTURED IN THIS COMPLAINT. " (B)(6) MALE WITH ASL-XR IMPLANT AND CORAIL STEM. IMPLANTED (B)(6) 2006. EXCISION ARTHROPLASTY FOR MRSA INFECTION, WORSENING PAIN, AND SUSPECTED LOOSENING OF ACETABULAR COMPONENT. INTRAOPERATIVE CONFIRMATION OF PSEUDOTUMOR, HETEROTOPIC OSSIFICATION, SOFT TISSUE NECROSIS, ACETABULAR OSTEOLYSIS WITH PELVIC DISCONTINUITY AND CUP LOOSENING, BLACK METAL STAINED PERIARTICULAR FLUID, PELVIC AND FEMORAL OSTEOLYSIS. PATIENT WAS NOT REVISED AS OF THIS WRITING BECAUSE HIS INFLAMMATORY AND INFECTION MARKERS WERE STILL TOO ELEVATED. EXCISION PERFORMED IN (B)(6) 2008 WITH POSITIVE HISTOLOGICAL IDENTIFICATION OF MRSA IN THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077941 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP KWA DEPUY INT'L LTD. 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention