BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT DUOFIX TAP SZ5 HI OFF

    MDR report key: 7596725 · Received June 13, 2018

    Report

    Report Number
    1818910-2018-62082
    Event Type
    Injury
    Date Received
    June 13, 2018
    Date of Event
    August 23, 2017
    Report Date
    May 14, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295060161
    PMA / PMN Number
    K011489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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.  ADDITIONAL NARRATIVE:  UDI: (B)(4).

    Description of Event or Problem · 0

    PPF ALLEGES METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS.

    Additional Manufacturer Narrative · 1

    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

    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). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PINNACLE LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES DEFECTIVE IMPLANTS THAT CAUSED DAMAGE TO PLAINTIFF'S HIP JOINT AND HIS BODY. DOI: (B)(6) 2009 ; DOR: NOT REPORTED (LEFT HIP) PINNACLE. UPDATE (B)(6) 2018: PFS AND MEDICAL RECORDS RECEIVED: PFS ALLEGES PAIN, LIMITED RANGE OF MOTION, DIFFICULTY PERFORMING DAILY ROUTINE, DIFFICULTY STANDING, SITTING, WALKING, LYING DOWN FOR EXTENDED PERIOD OF TIME, MENTAL ANGUISH, ANXIETY AND SORENESS. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT WAS REVISED DUE TO FAILED METAL LINER OF LEFT THA AND ALLEGES ELEVATED METAL IONS LEVELS. REVISION NOTE REPORTED DARKENED MATERIAL CONSISTENT WITH METALLOSIS, FOUND TO HAVE MORE METAL RESIDUE, SOME CATCHING ON THE FEMORAL NECK INDICATING IMPINGEMENT OF THE METAL COMPONENT. ON (B)(6) 2017 CLINICAL VISIT REPORTED HIGH LEVEL OF METAL IONS. ON (B)(6) 2017 CLINICAL REPORT LEFT HIP METAL REDUCTION MRI, (B)(6) 2017 CLINICAL VISIT REPORTED ELEVATED METAL IONS AND HIP ABDUCTION FOR 6 WEEKS. ON (B)(6) 2017 CLINICAL VISIT REPORTED LEFT HIP PAIN, ELEVATED METAL IONS, SWELLING RIGHT AND LEFT HIP, LEG LENGTH. ON (B)(6) 2017 AP PELVIS AND LEFT HIP VIEWS X-RAY RESULTS REPORTED THERE WERE ANTIBIOTIC BEADS IN THE GREATER TROCHANTER. SURGICAL PATHOLOGY REPORTED FOR LEFT HIP HARDWARE EXPLANTS ORTHOPEDIC HARDWARE PRESENT. LEFT HIP BONE AND SOFT TISSUE HAS MULTIPLE FRAGMENTS OF FIBROFATTY SOFT TISSUE AND BONE. LAB RESULTS SHOWS CHROMIUM AND COBALT ARE ABOVE 7 (NO UNIT PROVIDED. ADDED REVISION HOSPITAL, DATE OF EVENT, DOB, AGE, HEIGHT, WEIGHT, LAB DATA, MEDICAL HISTORY AND REVISION SURGEON. UPDATED DOR, PRODUCT DETAILS FOR LINER AND HEAD. ADDED STEM DUE TO ELEVATED METAL IONS AND BONE SCREW WAS REMOVED AS STATED IN THE OPERATIVE NOTE. CORRECTED PATIENT IDENTIFIER. DOI: (B)(6) 2009; DOR: (B)(6) 2017; LEFT HIP.

    Description of Event or Problem · 1

    PINNACLE LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES DEFECTIVE IMPLANTS THAT CAUSED DAMAGE TO PLAINTIFF'S HIP JOINT AND HIS BODY. DOI: (B)(6) 2009 ; DOR: NOT REPORTED (LEFT HIP) PINNACLE. PFS AND MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PFS ALLEGES PAIN, LIMITED RANGE OF MOTION, DIFFICULTY PERFORMING DAILY ROUTINE, DIFFICULTY STANDING, SITTING, WALKING, LYING DOWN FOR EXTENDED PERIOD OF TIME, MENTAL ANGUISH, ANXIETY AND SORENESS. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT WAS REVISED DUE TO FAILED METAL LINER OF LEFT THA AND ALLEGES ELEVATED METAL IONS LEVELS. REVISION NOTE REPORTED DARKENED MATERIAL CONSISTENT WITH METALLOSIS, FOUND TO HAVE MORE METAL RESIDUE, SOME CATCHING ON THE FEMORAL NECK INDICATING IMPINGEMENT OF THE METAL COMPONENTS. CLINIC VISITS REPORTED SWELLING AND LEG LENGTH DISCREPANCY. LAB RESULTS SHOWS METAL ION LEVELS ARE ABOVE 7PPB. ADDED STEM DUE TO ELEVATED METAL IONS BUT WAS NOT REVISED; ADDED CUP DUE TO REPORTED IMPINGEMENT BUT WAS NOT REVISED; AND ADDED A BONE SCREW SINCE IT WAS REMOVED. DOI: (B)(6) 2009; DOR: (B)(6) 2017; LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439971 SUMMIT DUOFIX TAP SZ5 HI OFF SUMMIT HIP STEM : HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US D2JC61 10603295060161

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention