BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 8887314 · Received August 13, 2019

    Report

    Report Number
    1818910-2019-100869
    Event Type
    Injury
    Date Received
    August 13, 2019
    Report Date
    August 2, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES 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 ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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). CITE: ARE METAL ION LEVELS A USEFUL TRIGGER FOR SURGICAL INTERVENTION? WILLIAM L. GRIFFIN, MD, THOMAS K. FEHRING, MD, JAMES C. KUDRNA, MD, ROBERT H. SCHMIDT, MD, MICHAEL J. CHRISTIE, MD, SUSAN M. ODUM, MED, AND ANNE C. DENNOS, BS PUBLISHED BY THE JOURNAL OF ARTHROPLASTY VOL. 27 NO. 8 SUPPL. 1 2012 DOI:10.1016/J.ARTH.2012.03.020. 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 ¿ARE METAL ION LEVELS A USEFUL TRIGGER FOR SURGICAL INTERVENTION¿ BY WILLIAM L>GRIFFIN ET AL REPORTS ON RETROSPECTIVE DETERMINATION OF WHETHER COBALT AND CHROMIUM LEVELS CAN PREDICT SOFT TISSUE DAMAGE AT THE TIME OF MOM TOTAL HIP REVISION OF 89 CASES. 84 OUT OF 89 WERE MONOBLOCK IMPLANTS NAMING ¿ 82 ASR (DEPUY), 1 CONSERVE (WRIGHT MEDICAL GROUP INC.), 1 MAGNUM (BIOMET) AND 5 MODULAR IMPLANTS (PINNACLE, DEPUY ORTHOPEDICS) WERE USED. REASONS FOR REVISION SURGERY WERE ASEPTIC LOOSENING, SUSPECTED METALLOSIS, PAIN AND NOISE. OF THESE CASES, 23 PATIENTS WERE CLASSIFIED BASED ON TISSUE DAMAGE, AS GRADE 0 (NO METALLOSIS), 38 PATIENTS WERE GRADE 1 (METALLIC STAINING, INTRACAPSULAR FLUID), 19 PATIENTS AS GRADE 2 (EXTRACAPSULAR FLUID) AND 9 PATIENTS AS GRADE 3 (EXTRACAPSULAR NECROSIS). THERE WAS LITTLE TO NO CORRELATION BETWEEN ION LEVELS AND TISSUE DAMAGE. HOWEVER, IT WAS OBSERVED THAT THE TISSUE DAMAGE SEEN AT REVISION SURGERY MAY BE RELATED TO THE LENGTH OF TIME OF METAL ION EXPOSURE BUT NOT THE EXPOSURE DOSE. NO CLARIFICATION WAS FOUND ON WHICH EVENTS WERE SPECIFICALLY PRESENT ON SPECIFIC PATIENTS. THE ARTICLE DOES NOT CLARIFY WHICH SPECIFIC EVENTS WERE ASSOCIATED WITH SPECIFIC PRODUCTS. HOWEVER, IT IS REASONABLE TO CONCLUDE THE ADVERSE EVENTS ARE RELATED TO DEPUY PRODUCTS AS THE MAJORITY OF IMPLANTS WERE DEPUY AND THE OTHER PRODUCTS ACCOUNTED FOR ONLY A TOTAL 2 OF THE CASES. REVISION REASONS WERE ASEPTIC LOOSENING (17 FREQUENCIES) - DEVICE AND/OR LOCATION UNSPECIFIED, SUSPECTED METALLOSIS (30 FREQUENCIES), PAIN (42 FREQUENCIES) AND NOISE (10 FREQUENCIES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680306 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP LPH DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention