BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPTION TYPE 1 TPR SLEVE +6

    MDR report key: 8848411 · Received July 31, 2019

    Report

    Report Number
    0001825034-2019-03281
    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
    LZO
    PMA / PMN Number
    K082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT HAS BEEN REPORTED ON 3002806535 - 2019 - 00812.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT HAS BEEN REPORTED ON 3002806535 - 2019 - 00812.

    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; 010000865, G7 NEUTRAL E1 LINER 40MM G 6233683, LINER; 650-1058, CER BIOLOXD OPTION HD 40MM 2982740, HEAD. 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. 0001825034-2019-03278 LINER. 0001825034-2019-03280 HEAD.

    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
    638956 CER OPTION TYPE 1 TPR SLEVE +6 PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 2959195

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O