BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 HI-WALL E1 LINER 40MM I

    MDR report key: 9163728 · Received October 7, 2019

    Report

    Report Number
    0001825034-2019-04518
    Event Type
    Injury
    Date Received
    October 7, 2019
    Date of Event
    August 25, 2019
    Report Date
    December 30, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL NOTES STATING PATIENT BENT OVER AND FELL ON THE FLOOR CAUSING HIP TO DISLOCATE, PATIENT UNDERWENT A CLOSED REDUCTION UNDER GENERAL ANESTHESIA. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO PATIENT FALLING AFTER LEANING TOO FALL FORWARD AS DIRECTED NOT TO POSTOP. 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 · 0

    IT WAS REPORTED THAT PATIENT FELL APPROXIMATELY 1 MONTH POST LEFT HIP PROCEDURE. THE NEXT DAY THE PATIENT UNDERWENT A CLOSED REDUCTION UNDER GENERAL ANESTHESIA. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION IS UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE LOCATION OF THE IMPLANT IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. UDI: (B)(4). CONCOMITANT MEDICAL PRODUCTS: PART # 010000670 G7 SHELL LOT # 6275966, PART # 51-103220 TPRLC 133 T1 PPS SO LOT# 6143346, PART # 650-1066 OPTION TAPER SLEEVE LOT# 2959127, PART # 650-1058 BIOLOXD OPTION HD LOT# 2982812. 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 PATIENT UNDERWENT L HIP CLOSED REDUCTION 1-MONTH POST IMPLANTATION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958366 G7 HI-WALL E1 LINER 40MM I PROSTESIS, HIP PBI ZIMMER BIOMET, INC. NI 6046200

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R