BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 8959787 · Received September 4, 2019

    Report

    Report Number
    1818910-2019-103005
    Event Type
    Injury
    Date Received
    September 4, 2019
    Date of Event
    August 28, 2012
    Report Date
    August 15, 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

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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

    PRODUCT COMPLAINT # (B)(4). CITE:"THE WITHDRAWN ASRTM THA AND HIP RESURFACING SYSTEMS HOW HAVE OUR PATIENTS FARED OVER 1 TO 6 YEARS?" BY KEVIN T. HUG MD, TYLER S. WATTERS MD, THOMAS P. VAIL MD, MICHAEL P. BOLOGNESI MD PUBLISHED BY CLINICAL ORTHOPAEDICS AND RELATED RESEARCH, CLIN ORTHOP RELAT RES (2013) 471:430¿438; DOI: 10.1007/S11999-012-2547-5. (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

    THE LITERATURE ARTICLE "THE WITHDRAWN ASRTM THA AND HIP RESURFACING SYSTEMS HOW HAVE OUR PATIENTS FARED OVER 1 TO 6 YEARS?" BY KEVIN T. HUG MD, TYLER S. WATTERS MD, THOMAS P. VAIL MD, MICHAEL P. BOLOGNESI MD PUBLISHED BY CLINICAL ORTHOPAEDICS AND RELATED RESEARCH, CLIN ORTHOP RELAT RES (2013) 471:430¿438; DOI: 10.1007/S11999-012-2547-5 ON 28 AUGUST 2012 WAS REVIEWED FOR REPORTABILITY. THE PURPOSE OF THE ARTICLE WAS FOR THE PHYSICIANS TO EVALUATE ALL ASR COMPONENTS IMPLANTED AT THEIR CENTER. THE ARTICLE REPORTS "BETWEEN OCTOBER 2004 AND JUNE 2010, 192 PATIENTS (214 HIPS) UNDERWENT PRIMARY THA USING THE ASRTM XL MOM ARTICULATION OR THE ASRTM HIP RESURFACING SYSTEM. WE PERFORMED 24 REVISIONS IN 18 PATIENTS WITH A THA AND IN FIVE PATIENTS WITH A HIP RESURFACING. THERE WERE NINE REVISIONS FOR ELEVATED METAL ION LEVELS AND PAIN CONCERNING FOR METALLOSIS (4.7% OF THE 190 HIPS), EIGHT FOR ASEPTIC ACETABULAR COMPONENT LOOSENING (4.2%), TWO FOR INFECTION (1.1%), ONE FOR ACETABULAR COMPONENT MALPOSITION (INCLINATION ANGLE: 60) (0.5%), ONE FOR ASEPTIC FEMORAL COMPONENT LOOSENING (0.5%), AND ONE FOR HETEROTOPIC OSSIFICATION (0.5%). THERE WERE TWO FEMORAL NECK FRACTURES IN THE HIP RESURFACING GROUP. ALL OTHER FEMORAL COMPONENTS WERE WELL FIXED AT THE TIME OF REVISION. THE PATIENTS WHO ULTIMATELY WERE REVISED FOR PAIN CONCERNING FOR METALLOSIS CHARACTERISTICALLY PRESENTED WITH MODERATE TO SEVERE PAIN PREDOMINANTLY IN THE GROIN WITH OCCASIONAL AUDIBLE CLUNKING." 4 OF THE 24 REVISIONS SUSPECTED OF ARMD WITH CONFIRMATION RESULTS WERE CAPTURED AND DESCRIBED IN DETAILED BY CASE IN TABLE 3 WITH 1 OF THE 14 ULTIMATELY CONFIRMED FOR CUP LOOSENING ONLY DUE TO LACK OF METALLIC TISSUE OR ALVAL. COBALT RANGES WERE "FROUND" 3-150NG/ML AND CHROMIUM 0-87NG/ML INDICATING ELEVATION ION LEVELS. ALL FEMORAL STEMS WERE FOUND TO BE WELL FIXED WITHOUT ADVERSE EVENTS. CASE 13- WITH THA IMPLANT WITH PREOPERATIVE MRI FINDINGS OF PSEUDOTUMOR. HISTOPATHOLOGY REVEALS POSITIVE PRESENCE OF METALLIC TISSUE AND POSITIVE FOR ALVAL. INTRAOPERATIVE FINDINGS INCLUDE ACETABULAR FIXATION TO BE WELL FIXED. OSTEOLYSIS: NONE. PATHOLOGY COMMENTS: PSEUDOTUMOR IN POSTERIOR CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755419 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention