BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 T1 PPS HO 13X146MM

    MDR report key: 8848421 · Received July 31, 2019

    Report

    Report Number
    0001825034-2019-03274
    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
    KWA
    PMA / PMN Number
    K101086
    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 RELEVANT TO THE REPORTED EVENT 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: 010000667, G7 PPS LTD ACET SHELL, 60G 6555005, SHELL; 010000865, G7 NEUTRAL E1 LINER 40MM, G 6233683, LINER; 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: 0001825034-2019-03276, SHELL; 0001825034-2019-03278, LINER; 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 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
    639345 TPRLC 133 T1 PPS HO 13X146MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 6498655

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O