BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 9146777 · Received October 2, 2019

    Report

    Report Number
    1818910-2019-107129
    Event Type
    Injury
    Date Received
    October 2, 2019
    Date of Event
    December 15, 2012
    Report Date
    September 12, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 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. (B)(4).

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE ENTITLED, "COBALT¿CHROMIUM TOXIC RETINOPATHY CASE STUDY" WRITTEN BY WARREN APEL, DENIS STARK, ANTHONY STARK, STEPHEN O¿HAGAN, AND JOSEPH LING PUBLISHED BY DOC OPHTHALMOL (2013) 126:69¿78 DOI 10.1007/S10633-012-9356-8 ON 15 DECEMBER 2012 WAS REVIEWED FOR MDR REPORTABILITY. THE ARTICLE REPORTS ON A CASE STUDY OF 65 YEAR OLD MALE WHO PRESENTED TO HIS OPHTHALMOLOGIST IN OCTOBER 2010. HIS HISTORY INCLUDES A DEPUY METAL FEMORAL HEAD IMPLANTED IN 2005. THE MALE HAD SEVERAL TESTS DUE TO PROBLEMS WITH VISION AND A CT OF ABDOMEN REVEALED "A CONSIDERABLE AMOUNT OF HETEROTOPIC BONE FORMATION POSTERIOR TO THE RIGHT HIP PROSTHESIS. MAY 2011 BLOOD TEST REVEALED A DIAGNOSED METAL TOXICITY COBALT LEVEL 355 MCG/L AND CHROMIUM LEVEL OF 39 MCG/L AND PEAKED IN JULY 2011 AT 446.4 MCG/L CO AND 46 MCG/L CR LEVELS. ERG WAS ABNORMAL IN ALL PHASES. PHOTOPIC RESPONSES WERE DELAYED AND REDUCED IN AMPLITUDE, AND THE SCOTOPIC ROD RESPONSES WERE ALSO MUCH REDUCED. THE MOC PROSTHESIS WAS REPLACED IN AUGUST 2011 RESULTING IN A MARKED DECREASE IN SERUM COBALT LEVELS. THE PATIENT FELT A SUBJECTIVE IMPROVEMENT IN HIS GENERAL HEALTH AND A NUMBER OF MEDICATIONS WERE CEASED. ERG, COLOR VISION AND VISUAL ELECTROPHYSIOLOGY TESTS PERFORMED 6 MONTHS FOLLOWING THE HIP REPLACEMENT ALL SHOWED IMPROVEMENT. THE ARTICLE DOES NOT IDENTIFY THE OTHER COMPONENTS AND MAKES NOTE THAT THE PAST MEDICAL HISTORY INCLUDES: "SIGNIFICANTLY THE REVISION OF A RIGHT CERAMIC ON CERAMIC HIP PROSTHESIS FOLLOWING FRACTURE OF ITS FEMORAL HEAD WITH A METAL DEPUY FEMORAL HEAD IN 2005." THE ARTICLE DOES NOT MENTION OF INTRAOPERATIVE FINDINGS AND ONLY REPORTS "THE MOC PROSTHESIS WAS REPLACED IN AUGUST 2011." ADVERSE EVENTS: METAL POISONING IMPACTED PRODUCT: DEPUY FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942437 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention