BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOCK-SCR CANCLS 6.5X40MM

    MDR report key: 7363366 · Received March 22, 2018

    Report

    Report Number
    0001825034-2018-01995
    Event Type
    Injury
    Date Received
    March 22, 2018
    Date of Event
    October 27, 2017
    Report Date
    March 16, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK991807
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: PM158036, JONES LT TRFNG SZ 26 HA W POST, 417450; UNKNOWN, UNKNOWN LINER, UNKNOWN; CP161940, TI LOCK-SCR CANCLS 6.5X15MM, 388730; CP161941, TI LOCK-SCR CANCLS 6.5X20MM, 683480; CP161942, TI LOCK-SCR CANCLS 6.5X25MM, 683500; CP161945, TI LOCK-SCR CANCLS 6.5X40MM, 683530; CP161947, TI LOCK-SCR CANCLS 6.5X50MM, 756760; CP161944, TI LOCK-SCR CANCLS 6.5X35MM, UNKNOWN; UNKNOWN, UNKNOWN HEAD, UNKNOWN; UNKNOWN, UNKNOWN STEM, UNKNOWN; CP161943, TI LOCK-SCR CANCLS 6.5X30MM, 683510; CP462153, CUS 9.5MM DRL GD, 463760; CP462154, CUS 9.5MM DRL GD INSERTER, 464350; CP161943, TI LOCK-SCR CANCLS 6.5X30MM, 683510; CP161943, TI LOCK-SCR CANCLS 6.5X30MM, 683510; CP161943, TI LOCK-SCR CANCLS 6.5X30MM, 683510; CP161942, TI LOCK-SCR CANCLS 6.5X25MM, 683500; CP161942, TI LOCK-SCR CANCLS 6.5X25MM, 683500; CP161942, TI LOCK-SCR CANCLS 6.5X25MM, 725760; CP161942, TI LOCK-SCR CANCLS 6.5X25MM, 725760; CP161942, TI LOCK-SCR CANCLS 6.5X25MM, 725760; CP161942, TI LOCK-SCR CANCLS 6.5X25MM, 725760; CP161942, TI LOCK-SCR CANCLS 6.5X25MM, 725760; CP161941, TI LOCK-SCR CANCLS 6.5X20MM, 683480; CP161941, TI LOCK-SCR CANCLS 6.5X20MM, 683480; CP161941, TI LOCK-SCR CANCLS 6.5X20MM, 683480. REPORT SOURCE, FOREIGN - THE EVENT OCCURRED IN THE (B)(6). 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 - 2017 - 10227, 0001825034 - 2017 - 10222, 0001825034 - 2017 - 10223, 0001825034 - 2017 - 10224, 0001825034 - 2017 - 10225, 0001825034 - 2017 - 10221, 0001825034 - 2017 - 10228, 0001825034 - 2017 - 10229, 0001825034 - 2017 - 10230, 0001825034 - 2017 - 10231, 0001825034 - 2017 - 10232, 0001825034 - 2018 - 01996, 0001825034 - 2018 - 01997, 0001825034 - 2018 - 01998, 0001825034 - 2018 - 01999, 0001825034 - 2018 - 02000, 0001825034 - 2018 - 02001, 0001825034 - 2018 - 02002, 0001825034 - 2018 - 02003, 0001825034 - 2018 - 02004, 0001825034 - 2018 - 02005, 0001825034 - 2018 - 02006, 0001825034 - 2018 - 02007, 0001825034 - 2018 - 02008. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 THE PATIENT WAS REVISED TO ADDRESS INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205541 TI LOCK-SCR CANCLS 6.5X40MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 683530

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O