BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 14X250MM SPL TPR DIST HA

    MDR report key: 7836811 · Received August 31, 2018

    Report

    Report Number
    0001825034-2017-10920
    Event Type
    Injury
    Date Received
    August 31, 2018
    Date of Event
    February 12, 2016
    Report Date
    December 5, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    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, 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, UNKNOWN HEAD. FOREIGN- (B)(6). THE COMPLAINT IS CONFIRMED AS THE FOLLOW UP VISIT NOTES WERE PROVIDED. DEVICE HISTORY RECORDS WERE REVIEWED AND IDENTIFIED NO DEVIATIONS AND/OR ANOMALIES RELATED TO THE REPORTED EVENT. X-RAYS WERE RECEIVED AND REVIEWED BY MMI. 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. TIP OF THE FEMORAL COMPONENT IS NOT SEEN ON ANY OF THE IMAGES LIMITING EVALUATION. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 10919, 0001825034 - 2017 - 10922, 0001825034 - 2017 - 10923, 0001825034 - 2018 - 08141, 0001825034 - 2018 - 08142.

    Description of Event or Problem · 1

    "T" WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POST OPERATIVE PAIN AFTER TWO YEAR TEN MONTHS POST REVISION SURGERY DUE TO INFECTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678126 ARCOS 14X250MM SPL TPR DIST HA PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 752090

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other