BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL AUGMENT

    MDR report key: 8828133 · Received July 25, 2019

    Report

    Report Number
    1818910-2019-99274
    Event Type
    Injury
    Date Received
    July 25, 2019
    Report Date
    July 22, 2019
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHESE CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT NULL. DEVICE HISTORY BATCH NULL. DEVICE HISTORY REVIEW NULL. 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). 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

    AN ARTICLE ¿RETRIEVAL ANALYSIS OF 240 METAL-ON-METAL HIP COMPONENTS, COMPARING MODULAR TOTAL HIP REPLACEMENT WITH HIP RESURFACING¿ BY A. MATTHIES ET AL REPORTS ON RETROSPECTIVE COMPARISON OF COMPONENT WEAR RATES AND PRE-REVISION BLOOD METAL IONS LEVELS IN TWO GROUPS OF FAILED METAL-ON-METAL HIP ARTHROPLASTIES: HIP RESURFACING AND MODULAR TOTAL HIP REPLACEMENT (THR). TOTAL 120 FAILED CURRENT-GENERATION MOM HIPS COUPLES (240 COMPONENTS ¿ 120 IN EACH) WERE COMPARED BETWEEN EXPLANTED MODULAR THRS (MEDIAN AGE -58, M: F=2:3) AND HIP RESURFACING'S (MEDIAN AGE -55, M: F=2:3). ASR IMPLANT WAS USED IN 26 AND 15 CASES OF MODULAR THR AND HIP RESURFACING GROUP RESPECTIVELY. FOLLOWING IMPLANTS WERE USED IN BOTH THE GROUPS: ADEPT (FINSBURY ORTHOPAEDICS), ASR (DEPUY), BHR (SMITH & NEPHEW), M2A-MAGNUM (BIOMET), CORMET (CORIN GROUP PLC), DUROM (ZIMMER), MITCH (STRYKER UK). MACROSCOPIC EXAMINATION REVEALED FINE SCRATCHING ON THE BEARING SURFACES AND IMPINGEMENT ON THE FEMORAL NECK OF THREE RESURFACING HEADS. EDGE-LOADED HIGH-WEARING ACETABULAR COMPONENTS HAVE BEEN SHOWN TO OCCUR ACROSS THE ENTIRE RANGE OF ACETABULAR INCLINATION FOR MODULAR THR AND HIP RESURFACING. ADVERSE ACETABULAR COMPONENT VERSION MAY BE AN IMPORTANT FACTOR RELATED TO EDGE LOADING IN THESE IMPLANTS WHICH HAD AN ACCEPTABLE INCLINATION ANGLE AND BE RESPONSIBLE FOR ELEVATED BLOOD METAL IONS. DISLOCATION, FRACTURE, INFECTION, LOOSENING AND UNEXPLAINED (PAIN) WERE REPORTED AS CAUSATIVE FACTOR OF THE FAILURE. NO CLARIFICATION WAS FOUND ON WHICH EVENTS WERE SPECIFICALLY PRESENT ON SPECIFIC PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619463 UNKNOWN HIP FEMORAL AUGMENT HIP FEMORAL AUGMENT KWA DEPUY INTERNATIONAL LTD. 8010379 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention