BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3787694 · Received May 2, 2014

    Report

    Report Number
    2520274-2014-11200
    Event Type
    Injury
    Date Received
    May 2, 2014
    Report Date
    April 15, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SEVERE OSTEOLYSIS AND SOFT TISSUE MASS AROUND TOTAL HIP ARTHROPLASTY: DESCRIPTION OF FOUR CASES AND REVIEW OF THE LITERATURE WITH RESPECT TO CLINICO-RADIOGRAPHIC AND PATHOLOGIC DIFFERENTIAL DIAGNOSIS. EUROPEAN JOURNAL OF RADIOLOGY 77 (2011) 43¿50. THIS REPORT IS FOR UNKNOWN PLATE. THE IMPLANT DATE AND EXPLANT DATE IS UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OF PART NUMBER WAS PROVIDED. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE. SEVERE OSTEOLYSIS AND SOFT TISSUE MASS AROUND TOTAL HIP ARTHROPLASTY: DESCRIPTION OF FOUR CASES AND REVIEW OF THE LITERATURE WITH RESPECT TO CLINICO-RADIOGRAPHIC AND PATHOLOGIC DIFFERENTIAL DIAGNOSIS; N. FABBRI, E. RUSTEMI, C. MASETTI, J. KRESHAK, M. GAMBAROTTI, D. VANEL, A. TONI, M. MERCURI. EUROPEAN JOURNAL OF RADIOLOGY 77 (2011) 43¿50. THE LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH. THIS IS A RETROSPECTIVE REVIEW OF A CASE OF MASSIVE PERIPROSTHETIC BONE DESTRUCTION ASSOCIATED WITH A LARGE SOFT TISSUE MASS AROUND A FAILED TOTAL HIP REPLACEMENT. A (B)(6) MAN PRESENTED ON SPRING 2008 TO THE EMERGENCY ROOM WITH A PERIPROSTHETIC RIGHT FEMORAL FRACTURE OCCURRED 3 DAYS BEFORE BECAUSE OF A DOWNFALL. BEFORE THE FALL, HE WAS FAIRLY LIMITED AND USING A WALKER EVEN FOR SHORT DISTANCES. HE REPORTED PROGRESSIVE LOSS OF FUNCTION AND MOBILITY ALONG WITH GRADUAL ONSET OF ACTIVITY RELATED HIP AND THIGH PAIN DURING THE PAST 5 YEARS. THE PATIENT HAD UNDERGONE RIGHT THA BECAUSE OF OSTEOARTHRITIS 27 YEARS BEFORE, IN 1981. SIX YEARS LATER, DUE TO ASEPTIC FAILURE, HE HAD UNDERGONE UNCEMENTED REVISION THA (NON-SYNTHES DEVICE). PAST MEDICAL HISTORY WAS REMARKABLE FOR HYPERTENSION, AND ISCHEMIC HEART DISEASE. PLAIN RADIOGRAPHS AT ADMISSION SHOWED A SPIROID FRACTURE AT THE LEVEL OF THE STEM, PROBABLE LOOSENING OF THE FEMORAL COMPONENT AND PELVIC OSTEOLYSIS WITH LOOSENING AND PROXIMAL MIGRATION OF THE ACETABULAR COMPONENT. BECAUSE OF THE OVERALL MEDICAL CONDITION, RELATIVELY LIMITED FUNCTIONAL GOAL AND POTENTIAL MORBIDITY RELATED WITH A COMPLEX RECONSTRUCTIVE PROCEDURE, IT WAS DECIDED TO SURGICALLY MANAGE THE FRACTURE BY OPEN REDUCTION AND INTERNAL FIXATION (LCP PLATE, SYNTHES, SWISS) WITHOUT UNDERTAKING REVISION OF THE IMPLANT. THE PATIENT HAD SATISFACTORY POSTOPERATIVE COURSE AND WAS DISCHARGED TO A REHAB FACILITY FEW DAYS AFTER SURGERY. AT 3 MONTHS FROM SURGERY PATIENT WAS DOING WELL, WITH NO PAIN ON PARTIAL WEIGHT BEARING AND RADIOGRAPHIC EVIDENCE OF HEALING AT THE FRACTURE SITE. HE CAME BACK 4 MONTHS LATER, 7 MONTHS FROM SURGERY, FOR RE-CHECK FOLLOWING ADMISSION ELSEWHERE IN INTERNAL MEDICINE FOR SEVERE ANAEMIA. HIS GENERAL STATUS HAD PROGRESSIVELY DETERIORATED AND ON PHYSICAL EXAMINATION HE PRESENTED WITH SEVERE PAIN AND SIGNIFICANT SWELLING OF THE RIGHT BUTTOCK, HIP AND THIGH. THERE WAS FIXED DEFORMITY IN ADDUCTION AND INTERNAL ROTATION OF THE RIGHT LOWER EXTREMITY AND COMPLETE FUNCTIONAL IMPAIRMENT. STANDARD RADIOGRAPHS DEMONSTRATED FURTHER SUPERIOR-LATERAL MIGRATION OF THE ACETABULAR COMPONENT FROM ITS PREVIOUS POSITION AND INCREASED PELVIC OSTEOLYSIS. DEFINITIVE HISTOPATHOLOGIC DIAGNOSIS OF ¿EPITHELIOID ANGIOSARCOMA¿ WAS MADE ON PERMANENT HISTOLOGIC SECTION. CHEST CT SCAN OBTAINED 2 DAYS BEFORE DEATH SHOWED BILATERAL WIDESPREAD METASTATIC DISEASE. THIS REPORT IS FOR UNKNOWN LCP PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264319 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention