BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 9099799 · Received September 20, 2019

    Report

    Report Number
    1818910-2019-105623
    Event Type
    Injury
    Date Received
    September 20, 2019
    Date of Event
    January 1, 2010
    Report Date
    August 30, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (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, ¿METAL-ON-METAL TOTAL HIP ARTHROPLASTY ADVERSE LOCAL TISSUE REACTION¿ BY CHARLES A. ENGH JR, MD, ET AL, PUBLISHED BY SEMINARS IN ARTHROPLASTY (2010), VOL. 21, PP. 19-23 WAS REVIEWED FOR MDR REPORTABILITY. THE PURPOSE OF THIS ARTICLE IS TO REPORT THE AUTHOR¿S EXPERIENCE WITH MOM BEARINGS WITH LARGE FEMORAL HEADS (DIAMETER: 36 MM) FROM A SINGLE MANUFACTURER. BEGINNING IN 2001, THE AUTHORS STARTED USING THE PINNACLE ACETABULAR CUP, ULTAMET LINER AND HEAD, AND THE ASR ACETABULAR SYSTEM ON 1164 PATIENTS WITH 1327 HIPS. THE PRIMARY DIAGNOSIS WAS OSTEOARTHRITIS (82.0%), FOLLOWED BY AVASCULAR NECROSIS (6.8%), DEVELOPMENTAL DYSPLASIA (6.6%), FRACTURE (2.7%), AND RHEUMATOID ARTHRITIS (1.9%). IN THE ACETABULAR SIDE, THE 36 MM MODULAR COMPONENT ACCOUNTS FOR 77.5% (1029 THAS), THE 40 OR 44 MM MODULAR COMPONENT ACCOUNTS FOR 19.0% (258 THAS), AND THE NONMODULAR ASR HAS BEEN PLACED IN 3.5% (40 THAS). ON THE FEMORAL SIDE, 56.7% (752 THAS) ARE PRODIGY STEM (DEPUY INC, WARSAW, IN), 26.8% (355 THAS) ARE AML STEM (DEPUY INC, WARSAW, IN), 11.5% (153 THAS) ARE SUMMIT STEM (DEPUY INC, WARSAW, IN), AND THE REST 5.0% (67 THAS) ARE OTHER STEM DESIGNS. THE CURRENT FOLLOW-UP IS SUCH THAT 12.5% OF THESE HIPS HAVE GREATER THAN A 5-YEAR FOLLOW-UP AND 22.3% HAVE BETWEEN 2- AND 5-YEAR FOLLOW-UP. THE MEAN FOLLOW-UP FOR ALL AVAILABLE CASES IS 2.6 ( 1.87, 0-8) YEARS. THE AUTHORS REPORT ALL KNOWN COMPONENT REVISIONS IN THE COHORT OF 1327 HIPS AND THE PERCENTAGE OF THOSE REVISIONS THAT WERE KNOWN TO HAVE A POSSIBLE TISSUE REACTION TO THE MOM BEARING. THE LATTER DIAGNOSIS WAS BASED ON THE GROSS INSPECTION OF THE WOUND AT THE TIME OF REVISION, INTRAOPERATIVE FINDING OF BIOPSIES, AND A LIGHT MICROSCOPIC ANALYSIS OF H&E STAINED PERIARTICULAR TISSUE PERFORMED BY A SINGLE INDEPENDENT PATHOLOGIST WITH EXPERTISE IN MOM BEARING SURFACE PATHOLOGY. THERE HAVE BEEN 17 REOPERATIONS ON THESE 1164 PATIENTS OR 1327 HIPS. TWELVE REOPERATIONS WERE NOT ASSOCIATED WITH EITHER GROSS OR MICROSCOPIC EVIDENCE OF AN ADVERSE REACTION TO THE METAL BEARING INCLUDED 4 CASES REVISED FOR INFECTION, 5 REVISED FOR STEM LOOSENING, 1 FOR STEM FRACTURE, 1 REVISED FOR A PERIPROSTHETIC FRACTURE, AND 1 FOR CUP LOOSENING (TABLE 1). FIVE OTHER REOPERATIONS ARE BELIEVED TO BE RELATED TO A LOCAL REACTION TO THE MOM BEARING AND HAVE BEEN CONFIRMED WITH HISTOLOGY (TABLE 2). THREE OF THE 5 REACTIONS PRESENTED WITH A MILKY-APPEARING FLUID AND A THICKENED JOINT CAPSULE (FIG. 1). TWO OF THE 5 CASES HAD A SECONDARY DIAGNOSIS OF INFECTION. BOTH OF THOSE CASES WERE PATIENTS IN WHICH THE SEVERITY OF THE REACTION HAD PROGRESSED TO THE APPEARANCE OF A PSEUDOTUMOR SEEN AT SURGERY WITH ASSOCIATED TISSUE NECROSIS. THE FIRST PATIENT HAD A PSEUDOTUMOR WITH A NECROTIC POSTERIOR PORTION OF THE GLUTEUS MEDIUS AND A SMALL PORTION OF NECROSIS IN THE GREATER TROCHANTER. THE SECOND PATIENT HAD A LARGE PSEUDOTUMOR THAT COMPLETELY DESTROYED THE HIP ABDUCTORS (FIG. 2). THESE 5 CASES REPRESENT 29% (5/17) OF THE REOPERATIONS DONE IN OUR SERIES OF MOM THAS. HISTOLOGY HAS BEEN PERFORMED ON 9 OF THE 17 REVISIONS. THE REMAINING 8 CASES THAT DO NOT HAVE HISTOLOGY EITHER OCCURRED BEFORE WE WERE AWARE OF THIS TYPE OF TISSUE REACTION OR THERE WERE NO SIGN OF METAL REACTION OR INFECTION DIAGNOSED INTRAOPERATIVELY AND THEREFORE TISSUE WAS NOT OBTAINED. OF THE 9 CASES THAT HAVE HAD A HISTOLOGY CONSULTATION, 5 WERE POSITIVE FOR A HISTOLOGIC APPEARANCE CONSISTENT WITH THE REACTION OCCURRING IN A MOM BEARING. THESE FIVE ARE LISTED AS CASES 13-17 WITHIN THE ATTACHED GUIDANCE DOCUMENT. PLEASE LINK ALL 17 PCS WITH THE PARENT (B)(4). EACH CASE HAS THE IMPACTED PRODUCTS AND ASSOCIATED PATIENT HARMS LISTED IN EACH INDIVIDUAL CASE TAB WITHIN THE GUIDANCE DOCUMENT. CASE 7 OF 17. LINK TO PARENT (B)(4). (B)(6) YEAR-OLD WITH BMI 33. INDEX THA: 03/2007. IMPLANTED WITH PINNACLE CUP, ULTAMET LINER, ULTAMET HEAD, AND SUMMIT STEM. LINER AND HEAD REVISION FOR EARLY INFECTION 0.3 YEARS AFTER INDEX THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891238 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Unknown Hospitalization| R