BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC BI-POLAR 28X44MM

    MDR report key: 2904799 · Received January 9, 2013

    Report

    Report Number
    0001825034-2013-00068
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    October 27, 2010
    Report Date
    December 17, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK051569
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE REASON FOR THE REVISION PROCEDURE AND PART AND LOT INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE, INFECTION, AND ALLERGIC REACTION." THIS REPORT IS NUMBER 1 OF 8 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-03548 / 03554 & 00068-1).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN; EXPIRATION DATE - UNKNOWN; DATE IMPLANTED - UNKNOWN; DATE EXPLANTED - UNKNOWN ; PMA/510(K) NUMBER/ MANUFACTURE DATE - UNKNOWN. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS NUMBER 8 STATES: DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN."

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT THE PATIENT UNDERWENT M2A HIP ARTHOPLASTY AND REPORTS PATIENT ALLEGATIONS OF PAIN AND DISLOCATION. SUBSEQUENTLY, PATIENT WAS REVISED ON AN UNKNOWN DATE. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2010. THE OPERATIVE REPORT NOTES PURULENT-LOOKING FLUID, CHRONIC FIBRILLATION AND EVIDENCE OF INFECTION WITH POCKETS OF NECROTIC DEBRIS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAIN THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT THE PATIENT UNDERWENT M2A HIP ARTHOPLASTY AND REPORTS PATIENT ALLEGATIONS OF PAIN AND DISLOCATION. SUBSEQUENTLY, PATIENT WAS REVISED ON AN UNKNOWN DATE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAIN THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11304 RINGLOC BI-POLAR 28X44MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 954120

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R