BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOCK-SCR CANCLS 6.5X30MM

    MDR report key: 7363336 · Received March 22, 2018

    Report

    Report Number
    0001825034-2018-01998
    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 INSTERTER, 464350 CP161945, TI LOCK-SCR CANCLS 6.5X40MM, 683530 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 (B)(6). 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. 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- 2018-01995, 0001825034- 2018-01996, 0001825034- 2018-01997, 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.

    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. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205403 TI LOCK-SCR CANCLS 6.5X30MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 683510

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O