BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 8971322 · Received September 6, 2019

    Report

    Report Number
    1818910-2019-103371
    Event Type
    Injury
    Date Received
    September 6, 2019
    Date of Event
    January 1, 2018
    Report Date
    August 23, 2019
    Manufacturer
    DEPUY INT'L LTD. 8010379
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. ADDITIONAL NARRATIVE: PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHES 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, 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

    ARTICLE RECEIVED ENTITLED: "INFECTION VERSUS ALVAL: ACUTE PRESENTATION WITH ABDOMINAL PAIN", BY NICOLE ABDUL, ET. AL, PUBLISHED IN ABDUL N, ET AL. BMJ CASE REP 2013. DOI: 10.1136/BCR-2013-009976. THE AUTHORS REPORT ON A SINGLE CASE, A (B)(6) YEAR OLD MAN WHO UNDERWENT BILATERAL ASR HIP RESURFACING PROCEDURES IN JUNE 2006. THEN, FOLLOWING A POST-OP DAY 4 FEMORAL NECK FRACTURE, THE PATIENT UNDERWENT A RIGHT HIP REVISION TO A DEPUY CEMENTED C-STEM, WITH AN ASR XL TAPER SLEEVE ADAPTOR, EFFECTIVELY CONVERTING THE ASR RESURFACING DEVICE TO AN ASR XL CONSTRUCT. AFTER UNEVENTFUL FIVE YEAR FOLLOW-UP, PATIENT PRESENTED TO ER. FOLLOWING A ROUND OF GOLF PATIENT HAD FELT A SPONTANEOUS SHARP PAIN IN HIS RIGHT GROIN AND ABDOMEN, LOST HIS BALANCE AND FELL. HE WAS ADMITTED TO ER AND ON EXAMINATION WAS FOUND TO BE FEVERISH WITH TENDER HEPATOMEGALY. BLOOD TESTS SHOWED HIS WHITE CELL COUNT (13.5 ×109/L) AND INFLAMMATORY MARKERS (C REACTIVE PROTEIN 207 MG/L) TO BE RAISED AND HIS LIVER FUNCTION TESTS DERANGED. EXAMINATION REVEALED FEVER AND A TENDER EPIGASTRIUM. ON EXAMINATION THE RIGHT HIP WAS COMFORTABLE IN FLEXION, HAD NORMAL ABDUCTION BUT PAINFUL ADDUCTION. A PELVIC CT SCAN WAS REPORTED AS SHOWING A 5 CM DIAMETER PSOAS ABSCESS. INTRAVENOUS ANTIBIOTICS WERE STARTED. TWENTY-FOUR HOURS AFTER ADMISSION THE PATIENT WAS SEEN BY THE ORTHOPAEDIC ON-CALL TEAM, AND FOR FURTHER CLARIFICATION AN MRI WAS PERFORMED SHOWING A RIGHT ILIOPSOAS COLLECTION (6×4×5 CM) WHICH APPEARED TO COMMUNICATE WITH THE HIP JOINT. EXTENSIVE METAL DEBRIS WAS SEEN BUT THERE WAS NO EVIDENCE OF SIGNIFICANT PERIPROSTHETIC OSTEOLYSIS. THE INITIAL MEDICAL DIFFERENTIAL DIAGNOSES WERE (1) BILIARY SEPSIS,(2) URINARY TRACT INFECTION AND (3) SEPTIC ARTHRITIS. FOLLOWING ORTHOPAEDIC REVIEW BY SENIOR DOCTORS AND THE MRI SCAN RESULTS, THE DIFFERENTIAL DIAGNOSES WERE ALTERED TO (1) ALVAL AND (2) INFECTED THR. THE PATIENT UNDERWENT A DIRECT EXCHANGE OF THE RIGHT HIP PROSTHESIS. AT SURGERY A WHITE CREAMY COLLECTION WAS VISUALISED WITHIN THE HIP JOINT, THERE WAS BLACK STAINING OF THE TRUNNION, MACROSCOPIC WEAR OF THE STEM TAPER, AND GRANULOMATOUS TISSUE IN LINE WITH THE PSOAS TENDON. THE INTRAOPERATIVE CLINICAL PICTURE WAS HIGHLY SUGGESTIVE OF ALVAL AND NOT AN INFECTIVE PROCESS, PSOAS ABSCESS OR ABDOMINAL PATHOLOGY. FIVE INTRAOPERATIVE TISSUE SAMPLES TAKEN WERE SENT FOR PROLONGED AEROBIC AND ANAEROBIC CULTURE WHICH SUBSEQUENTLY REVEALED NO EVIDENCE OF INFECTION. THE HIP WAS REVISED TO A DURALOC DEPUY UNCEMENTED CUP WITH A CERAMIC LINER AND A SHORT STEM COMPETITOR CEMENTED FEMORAL STEM WITH A COMPETITOR 32 MM CERAMIC HEAD. SERUM COBALT (CO)/CHROMIUM (CR) LEVELS TAKEN ON ADMISSION; 7.00 MG/L (PPB) FOR CO, CR. CO 6.14 MG/L (PPB) AND CR 9.00 MG/L (PPB) SUGGESTING AN EXCESSIVE METAL ION RELEASE IN KEEPING WITH THE DIAGNOSIS OF ALVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765939 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD JDI DEPUY INT'L LTD. 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention