BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL E1 LINER 40MM G

    MDR report key: 8848413 · Received July 31, 2019

    Report

    Report Number
    0001825034-2019-03278
    Event Type
    Injury
    Date Received
    July 31, 2019
    Date of Event
    July 4, 2019
    Report Date
    October 17, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UDI : (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MEDICAL RECORDS INDICATE A DELAY IN DISCHARGE BY FOUR DAYS DUE TO ORTHOSTATIC HYPOTENSION. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 51-104130, TPRLC 133 T1 PPS HO 13X146MM, 6498655, STEM; 010000667, G7 PPS LTD ACET SHELL 60G, 6555005, SHELL; 650-1058, CER BIOLOXD OPTION HD 40MM, 2982740, HEAD; 650-1068, CER OPTION TYPE 1 TPR SLEVE +6, 2959195, SLEEVE. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-03274 STEM, 0001825034-2019-03276 SHELL, 0001825034-2019-03280 HEAD, 0001825034-2019-03281 SLEEVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY LEFT THA. THE FOLLOWING DAY THAT THE PATIENT EXPERIENCED ORTHOSTATIC HYPOTENSION AND THIS DELAYED THE PATIENTS DISCHARGE FROM THE HOSPITAL. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639341 G7 NEUTRAL E1 LINER 40MM G PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6233683

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O