BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL LOCKING SCREW

    MDR report key: 7438381 · Received April 17, 2018

    Report

    Report Number
    0001825034-2018-02814
    Event Type
    Injury
    Date Received
    April 17, 2018
    Report Date
    January 21, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS DISCARDED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DATE OF EVENT - UNKNOWN DATE IN (B)(6) 2018. EXPLANT DATE - UNKNOWN DATE IN (B)(6) 2018. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 00-2232-004-18, ITEM NAME: CABLE, LOT NUMBER: 63429957, ITEM NUMBER: 00-2232-004-18, ITEM NAME: CABLE, LOT NUMBER: 63597298, ITEM NUMBER: 00-6250-065-40, ITEM NAME: SELF-TAP SCREW, LOT NUMBER: 63566054, ITEM NUMBER: 00-6250-065-40, ITEM NAME: SELF-TAP SCREW, LOT NUMBER: 63569247, ITEM NUMBER: 010000671, ITEM NAME: G7 ACETABULAR SHELL, LOT NUMBER: 3822396, ITEM NUMBER: 11-302136, ITEM NAME: ARCOS TROCHANTERIC BOLT, LOT NUMBER: 814260, ITEM NUMBER: 110010571, ITEM NAME: G7 SUCTION CUP STERILE, LOT NUMBER: 791300, ITEM NUMBER: 110024467, ITEM NAME: G7 DUAL MOBILITY LINER, LOT NUMBER: 956050, ITEM NUMBER: 650-1055, ITEM NAME: DELTA CERAMIC OPTION HEAD, LOT NUMBER: 096830, ITEM NUMBER: 650-1067, ITEM NAME: OPTION TAPER SLEEVE, LOT NUMBER: 3246463, ITEM NUMBER: EP-200160, ITEM NAME: E1 ACTIVE ARTICULATION INSERT, LOT NUMBER: 339230, ITEM NUMBER: 11-302102, ITEM NAME: ARCOS TROCHANTERIC CLAW, LOT NUMBER: 603340. COMPLAINT REPORTED FROM (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 02815. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT HIP REVISION DUE TO PAIN OF THE TROCHANTERIC CLAW AND DISTAL SCREW, BOTH WERE REMOVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279920 FEMORAL LOCKING SCREW PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 097770

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R