BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HEAD

    MDR report key: 7842023 · Received September 4, 2018

    Report

    Report Number
    0001825034-2018-08058
    Event Type
    Injury
    Date Received
    September 4, 2018
    Date of Event
    February 12, 2016
    Report Date
    September 4, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 22-301310 ARCOS CON SZ A HI 50MM HA 860790; 22-301014 ARCOS 14X250MM SPL TPR DIST HA 752090; PT-125464 REGENEREX ACET SHELL 64ODX54ID 464070; XL-223652 HWAL ARCOMXL ALLPOLY 36IDX52OD 555790; 103531 TI LOW PROFILE SCREW 6.5X20MM 289902; 103531 TI LOW PROFILE SCREW 6.5X20MM 2888144; 103532 BM ACET LP DOME SCW TI S/TAP DIA6.5X25MM 2901771; 103532 BM ACET LP DOME SCW TI S/TAP DIA6.5X25MM 2578544; 103532 BM ACET LP DOME SCW TI S/TAP DIA6.5X25MM 2909284; 103533 TI LOW PROFILE SCREW 6.5X30MM 2915885; UNKNOWN CABLE ATTACHMENT -QTY 2. FOREIGN- (B)(6). THE COMPLAINT IS CONFIRMED AS THE FOLLOW UP VISIT NOTES WERE PROVIDED. DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE PRODUCT INFORMATION WAS NOT PROVIDED. X-RAYS WERE RECEIVED AND REVIEWED OVERALL FIT AND ALIGNMENT OF THE IMPLANTS IS APPROPRIATE. NO DEFINITE EVIDENCE FOR WEAR. NO METALLIC PARTICLES ARE SEEN. OF NOTE, ON SEVERAL OF THE IMAGES, MEDIAL TO THE PROXIMAL FEMORAL DIAPHYSIS, THERE IS EVIDENCE OF FRAGMENTS PRESENT, UNCERTAIN ETIOLOGY, POSSIBLY WIRE HOWEVER THIS IS UNCONFIRMED. ON SEVERAL OF THE IMAGES, THERE IS LINEAR LUCENCY ALONG THE LATERAL ASPECT OF THE PROXIMAL TO MID LEFT FEMORAL DIAPHYSIS SUGGESTING INCOMPLETE FRACTURE. POSSIBLE CONTRIBUTING FACTORS TO THE PAIN COULD BE THE RADIOLUCENCY NOTED WHICH COULD SUGGEST AN INCOMPLETE FRACTURE. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POST OPERATIVE PAIN APPROXIMATELY THREE (3) YEARS POST REVISION SURGERY OF THE LEFT HIP. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683316 UNKNOWN HEAD PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other