BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DISTAL LOCKING SCREW

    MDR report key: 3597322 · Received January 29, 2014

    Report

    Report Number
    0001825034-2014-00546
    Event Type
    Injury
    Date Received
    January 29, 2014
    Date of Event
    October 17, 2011
    Report Date
    August 22, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXT
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. CONCOMITANT DEVICES: A 2.2MM X 28 GUIDE WIRE, CATALOG #: 8092-22-028, LOT #: E2PAG7. VERSANAIL TIBIOTALOCALCANEAL ANKLE FUSION NAIL, CATALOG #: 8007-10-025, LOT #: DLNCL1. ENDCAP IMPINGING, CATALOG #: 8007-00-000, LOT #: DLDBCF. 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. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034-2017-02592).

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. PMA/510(K) NUMBER. MANUFACTURE DATE ¿ UNKNOWN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. (NOTE: BIOMET, INC. ACQUIRED THE TRAUMA PRODUCT LINE FROM DEPUY ORTHOPAEDICS, INC. (¿DEPUY¿) ON JUNE 16, 2012 (¿CLOSING DATE¿). PURSUANT TO THE WRITTEN AGREEMENT BETWEEN BIOMET AND DEPUY, BIOMET AGREED TO BE RESPONSIBLE FOR REGULATORY REPORTING FOR EVENTS WHICH OCCURRED AFTER THE CLOSING DATE REGARDLESS OF THE ENTITY THAT ACTUALLY MANUFACTURED THE PRODUCT OR ACTUALLY SOLD THE PRODUCT TO THE HEALTHCARE PROVIDER. BECAUSE THE PRODUCT THAT IS THE SUBJECT MATTER WAS MANUFACTURED BEFORE THE CLOSING DATE, PLEASE BE ADVISED THAT THE SUBJECT PRODUCT WAS MANUFACTURED BY DEPUY AND NOT BIOMET.) DEPUY ALSO SOLD THE PRODUCT THAT IS THE SUBJECT MATTER TO THE HEALTHCARE PROVIDER INVOLVED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. FURTHER REVIEW OF MEDICAL RECORDS WAS PERFORMED AND IS SUMMARIZED AS FOLLOWS: "REVIEW OF PATIENT MEDICAL RECORDS INDICATES THE PATIENT UNDERWENT RIGHT ANKLE ORIF IN 2005. SUBSEQUENTLY, THE PATIENT UNDERWENT ARTHRODESIS OF THE RIGHT ANKLE ON (B)(6) 2011 DUE TO PROXIMAL TIBIA FRACTURE. RADIOGRAPH IMAGES TAKEN PRIOR TO THE REVISION PROCEDURE SHOW THE ROD IS IN PROPER POSITION BUT THAT THE DISTAL LOCKING SCREW HAD BACKED OUT. THERE IS A MASS VISIBLE ON THE PATIENT¿S RIGHT ANKLE WHERE THE SCREW HAS BACKED OUT. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2011. THE DISTAL LOCKING SCREW WAS REMOVED. MEDICAL RECORDS ALSO STATE THAT THE PATIENT FELL ON (B)(6) 2011." DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. REVIEW OF THE COMPLAINT HISTORY WAS UNABLE TO BE PERFORMED AS PART AND LOT NUMBERS OF DEVICE ARE UNKNOWN. 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

    MEDICAL RECORDS PROVIDED BY PATIENT'S LEGAL COUNSEL INDICATE THAT PATIENT UNDERWENT A RIGHT ANKLE OPEN REDUCTION INTERNAL FIXATION IN 2005. SUBSEQUENTLY, PATIENT UNDERWENT AN ARTHRODESIS PROCEDURE ON (B)(6) 2011 DUE TO A FRACTURED PROXIMAL TIBIA. OPERATIVE REPORT NOTED THE PATIENT FELL ON (B)(6) 2011. PATIENT WAS FURTHER REVISED ON (B)(6) 2011 DUE TO A DISTAL LOCKING SCREW BACKING OUT. THE DISTAL LOCKING SCREW WAS REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A RIGHT ANKLE FUSION REVISION DUE TO DISTAL LOCKING SCREW MIGRATION SEVEN MONTHS FOLLOWING IMPLANTATION. THE DISTAL LOCKING SCREW WAS REMOVED. OPERATIVE NOTES PROVIDED INDICATE THAT, "THE DISTAL SCREW WAS EASILY CAUSING PROBLEMS. THE PROXIMAL SCREW IS DEEP, TIGHT AND WITHOUT WIND SHIELD WIPER SIGN. I TOOK MANY OBLIQUES OF THE CALCANEUS AND COULD NOT SEE ANY ABNORMALITY...THE SCREW WAS REMOVED WITH A SCREWDRIVER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63578 UNKNOWN DISTAL LOCKING SCREW APPLIANCE, FIXATION LXT BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R