BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIRIUS POLISHED CEMENTED STEM

    MDR report key: 6724784 · Received July 19, 2017

    Report

    Report Number
    0001825034-2017-05044
    Event Type
    Injury
    Date Received
    July 19, 2017
    Date of Event
    March 29, 2017
    Report Date
    March 15, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK130610
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS XL-053660 NAME: RLOC-X ARCOMXL H/W 60/36MM UK LOT: 3858818 131360 NAME: EXC ABT RNGLC-X SHELL PC 060MM LOT: 3873356. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. X-RAY REVIEW BY RADIOLOGIST STATES NORMAL ALIGNMENT AND FIT OF THE ARTHROPLASTY. THE STEM IS SURROUNDED BY CEMENT. FAINT LUCENCY NOTED DISTAL TO THE TIP OF THE FEMORAL STEM. THE REMAINDER OF HARDWARE, CEMENT, AND BONES APPEARS NORMAL. LATERAL - THE PERIPROSTHETIC LUCENCY MENTIONED ABOVE IS MORE APPARENT TO THE STEM TIP. ALSO, A MILD AMOUNT OF LUCENCY SURROUNDS THE CEMENT. GIVEN THAT IT IS ASSUMED THIS IS IMMEDIATE POSTOP, LOOSENING/INFECTION IS NOT ASSUMED. BUT THIS HAS TO BE FOLLOWED UP AGAIN SEE IF THIS CHANGES. IF IT IS SOME TIME SINCE THE OPERATION, THEN THE DIFFERENTIAL WOULD BE CHANGED. PERIPROSTHETIC LUCENCIES SURROUNDING THE HARDWARE AND CEMENT. ASSUMING THIS IS IMMEDIATELY POSTOP, THIS IS NONSPECIFIC IN ITS EARLY POSTOP STAGE. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, (STILL IMPLANTED). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DATE OF BIRTH - UNKNOWN DATE IN (B)(6). CONCOMITANT PRODUCTS: BIOMET HIP SYSTEM MODULAR HEAD COMPONENT P/N 11-363664 L/N 654710; POLISHED CEMENTED STEM P/N 51-199343 L/N 424640. REPORT SOURCE - (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2017-05043, 0001825034-2017-05044.

    Description of Event or Problem · 1

    IT WAS REPORTED ONE MONTH POST-IMPLANTATION PATIENT EXPERIENCED SWELLING AND PAIN IN LOWER LIMB WITH OOZING FROM THE WOUND. PATIENT WAS DIAGNOSED WITH ERYSIPELAS AND TREATED WITH PRIMCILLIN. SHORTLY AFTER PATIENT WAS DIAGNOSED WITH ERYSIPELAS AGAIN AND WAS TREATED WITH PRIMCILLIN. AT THREE MONTH FOLLOW-UP PATIENT WAS EXPERIENCING NO PROBLEM. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED ONE MONTH POST-IMPLANTATION PATIENT EXPERIENCED SWELLING AND PAIN IN LOWER LIMB. PATIENT WAS DIAGNOSED WITH ERYSIPELAS AND TREATED WITH PRIMCILLIN. SHORTLY AFTER PATIENT WAS DIAGNOSED WITH ERYSIPELAS AGAIN AND WAS TREATED WITH PRIMCILLIN. AT THREE MONTH FOLLOW-UP PATIENT WAS EXPERIENCING NO PROBLEM. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507070 SIRIUS POLISHED CEMENTED STEM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 424640

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R SEE H10