BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR BIOMET FEM HD -3 NK

    MDR report key: 7810922 · Received August 23, 2018

    Report

    Report Number
    0001825034-2018-08519
    Event Type
    Injury
    Date Received
    August 23, 2018
    Date of Event
    February 12, 2016
    Report Date
    August 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    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). FOREIGN: (B)(6). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET US AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, CONCOMITANT MEDICAL PRODUCTS: 22-301303 ARCOS CON SZ C STD 60MM HA 682750; 22-300817 ARCOS 17X150MM SPL TPR DIST HA 047050; PT-125464 REGENEREX ACET SHELL 64ODX54ID 478150; XL-223654 HWAL ARCOMXL ALLPOLY 36IDX54OD 710780; 103531 TI LOW PROFILE SCREW 6.5X20MM 3187124; 103531 TI LOW PROFILE SCREW 6.5X20MM 3147716; 103533 TI LOW PROFILE SCREW 6.5X30MM 2915874; 103536 TI LOW PROFILE SCREW 6.5X45MM 2846235; UNKNOWN CERCLAGE WIRES. THE COMPLAINT CAN BE CONFIRMED BASED ON THE INFORMATION PROVIDED FROM THE CLINICAL STUDY AND X-RAYS. THE X-RAY REVIEW SHOWS OVERALL FIT AND ALIGNMENT OF THE IMPLANT IS APPROPRIATE. NO OBVIOUS SIGNS OF LOOSENING OR RADIOLUCENCY SEEN ON THESE IMAGES. RADIOLOGIST NOTED A PROXIMAL CERCLAGE WIRE IS FRACTURED ON THE 1 YR & 3 YR IMAGE. RADIOLOGIST NOTES PERSISTENT FRACTURE INVOLVING THE PROXIMAL LEFT FEMORAL DIAPHYSIS ON IMMEDIATE POST OP AND 3 YR IMAGE. DEVICE HISTORY RECORDS REVIEWED AND IDENTIFIED NO DEVIATIONS OR ANOMALIES THAT COULD LEAD TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE PROVIDED BASED ON THE INFORMATION PROVIDED. THE WIRE FRACTURE AND DIAPHYSIS FRACTURE COULD BE CONTRIBUTING FACTORS TO THE REPORTED PATIENT¿S CONDITION. IT IS UNCONFIRMED IF THE FRACTURE IS A NONUNION OF THE PREVIOUS FRACTURE OR A NEW ONE FORMED AS A RESULT OF THE CERCLAGE WIRE FRACTURE. 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

    UPON REASSESSMENT OF THE REPORTED EVENT IT WAS DETERMINED THAT THE MANUFACTURING SITE IS MFR: (B)(4). HENCE THIS EVENT WILL BE SUBMITTED ON 3002806535-2018-01018 AND THE INITIAL REPORT SUBMITTED SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A CLINICAL STUDY THAT THE PATIENT WAS EXPERIENCING MODERATE LEFT HIP PAIN, DIFFICULTIES AMBULATING, DIFFICULTY PERFORMING ACTIVITIES OF DAILY LIVING AT A THREE YEAR FOLLOW UP AFTER PRIMARY SURGERY. NO OTHER ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649238 36MM COCR BIOMET FEM HD -3 NK PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 1524524

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other