BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOCK-SCR CANCLS 6.5X40MM

    MDR report key: 7029557 · Received November 14, 2017

    Report

    Report Number
    0001825034-2017-10228
    Event Type
    Injury
    Date Received
    November 14, 2017
    Date of Event
    October 27, 2017
    Report Date
    March 7, 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

    CONCOMITANT MEDICAL PRODUCTS: PM158036 JONES LT TRFNG SZ 26 H LOT 417450, CP462153 CUS 9.5MM DRL GD 1 LOT 463760, CP462154 CUS 9.5MM DRL GD INSTE LOT 464350, CP161940 TI LOCK-SCR CANCLS 6.5 LOT 388730, CP161941 TI LOCK-SCR CANCLS 6.5 LOT 683480, CP161942 TI LOCK-SCR CANCLS 6.5 LOT 725760, CP161942 TI LOCK-SCR CANCLS 6.5 LOT 683500, CP161943 TI LOCK-SCR CANCLS 6.5 LOT 683510, CP161945 TI LOCK-SCR CANCLS 6.5 LOT 683530, CP161947 TI LOCK-SCR CANCLS 6.5 LOT 756760. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: (B)(4), TI LOCK-SCR CANCLS 6.5X15MM, UNKNOWN; (B)(4), TI LOCK-SCR CANCLS 6.5X20MM, UNKNOWN; (B)(4), TI LOCK-SCR CANCLS 6.5X25MM, UNKNOWN; (B)(4), TI LOCK-SCR CANCLS 6.5X30MM, UNKNOWN; (B)(4), TI LOCK-SCR CANCLS 6.5X35MM, UNKNOWN; (B)(4), JONES LT TRFNG SZ 26 HA W POST, UNKNOWN; (B)(4), TI LOCK-SCR CANCLS 6.5X50MM, UNKNOWN; UNKNOWN, UNKNOWN HEAD, UNKNOWN; UNKNOWN, UNKNOWN LINER, UNKNOWN; UNKNOWN, UNKNOWN STEM, UNKNOWN. REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN (B)(6). CUSTOMER HAS BEEN 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 - 10222; 0001825034 - 2017 - 10223; 0001825034 - 2017 - 10224; 0001825034 - 2017 - 10225; 0001825034 - 2017 - 10227; 0001825034 - 2017 - 10221; 0001825034 - 2017 - 10229; 0001825034 - 2017 - 10230; 0001825034 - 2017 - 10231; 0001825034 - 2017 - 10232.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT HIP PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT HAS BEEN INDICATED FOR REVISION DUE TO INFECTION. ALL PRODUCTS NEED TO BE REMOVED IN ORDER TO RETRIEVE THE POST FROM THE TRIFLANGE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808118 TI LOCK-SCR CANCLS 6.5X40MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 683530

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O