BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR HEAD COMPONENT

    MDR report key: 6556182 · Received May 9, 2017

    Report

    Report Number
    0001825034-2017-02888
    Event Type
    Injury
    Date Received
    May 9, 2017
    Report Date
    January 2, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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). CONCOMITANT MEDICAL PRODUCTS: MODULAR HEAD COMPONENT, P/N 163668, L/N 124190; ARCOM XL RINGLOC ACETABULAR LINER, P/N XL-108222, L/N 392250; TI LOW PROFILE SCREW, P/N 103532, L/N 016560; RINGLOC ACETABULAR DRILL BIT, P/N 31-323230, L/N 421050; 14-103648, UNIVERSAL 2-HOLE SHELL LINER; BI-METRIC ECHO PROFILE, P/N 192411, L/N 967590. IT IS UNKNOWN IF PRODUCT WILL 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: 0001825034-2017-02888; 0001825034-2017-02898.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S RIGHT HIP DISLOCATED TEN MONTHS POST HIP ARTHROPLASTY AND REQUIRED SURGICAL INTERVENTION TO CORRECT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE, HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION PROCEDURE TEN MONTHS AFTER POST-IMPLANTATION DUE TO DISLOCATION. THE PROCEDURE REQUIRED EMERGENCY SURGERY TO CORRECT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY LEGAL COUNSEL THAT PATIENT UNDERWENT A SURGICAL EMERGENCY PROCEDURE 10 MONTHS POST IMPLANTATION DUE TO DISLOCATION. LEGAL COUNSEL FURTHER REPORTED THAT PATIENT UNDERWENT A NON-SURGICAL PROCEDURE 1 YEAR POST IMPLANTATION DUE TO A 2ND DISLOCATION OF RIGHT HIP. LEGAL COUNSEL FURTHER REPORTED PATIENT UNDERWENT A CORRECTIVE PROCEDURE ON AN UNKNOWN DATE TO REPOSITION THE HIP AND REPLACE PART OF THE PROSTHESIS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335423 MODULAR HEAD COMPONENT PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 124190

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R