BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 FREEDOM CONST E1 LNR 36MM G

    MDR report key: 8699888 · Received June 14, 2019

    Report

    Report Number
    0001825034-2019-02568
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    May 15, 2019
    Report Date
    September 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OQI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02567, 0001825034-2019-02568, 0001825034-2019-03752, 0001825034-2019-03754.

    Additional Manufacturer Narrative · 0

    UDI: (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. XRAY REVIEW NOTES DISLOCATION OF THE FEMORAL HEAD AND POLYETHYLENE LINER, AND HETEROTOPIC OSSIFICATION ALONG THE GREATER TROCHANTER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DOB - UNKNOWN DATE IN (B)(6) 1962.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY, SUBSEQUENTLY THE PATIENT UNDERWENT A REVISION DUE TO RECURRENT DISLOCATION APPROXIMATELY FOUR WEEKS POST-IMPLANTATION. A REVIEW OF THE X-RAYS NOTED HETEROTOPIC OSSIFICATION ALONG THE GREATER TROCHANTER AND LATERAL ASPECT THE PROXIMAL FEMORAL DIAPHYSIS. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PATIENT IDENTIFIER: (B)(4). CONCOMITANT MEDICAL PRODUCTS: PART: 11-107018, FREEDOM CONSTR HD 36MM T1 STD, LOT: 062190; PART: 010000985, G7 FREEDOM CONST E1 LNR 36MM G, LOT: 6517058; PART: 010000666, G7 PPS LTD ACET SHELL 58G, LOT: 6320695; PART: 110024465, G7 DUAL MOBILITY LINER 46MM G, LOT: 143090; PART: 11-301354, ARCOS CON SZ D HI 80MM, LOT: 393990; PART: 11-300920, ARCOS 20X190MM SPL TPR DIST, LOT: 751510. REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: HEAD: 0001825034-2019-02567, LINER: 0001825034-2019-02568.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED AND SUBSEQUENTLY WAS REVISED AGAIN APPROXIMATELY 1 MONTH LATER DUE TO DISLOCATION. ALL COMPONENTS WERE REVISED DURING THIS SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492212 G7 FREEDOM CONST E1 LNR 36MM G PROSTHESIS, HIP OQI ZIMMER BIOMET, INC. N/A 6517058

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R