BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIA COCR MOD HD STD NK

    MDR report key: 3812182 · Received May 15, 2014

    Report

    Report Number
    0001825034-2014-04029
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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 1 STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ NUMBER 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿ THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN, DATE EXPLANTED - UNKNOWN. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04209 / 04210).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2012 AND RIGHT TOTAL HIP ARTHROPLASTY OCCURRED ON (B)(6) 2013. LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE/TISSUE, LACK OF MOBILITY, LOSS OF RANGE OF MOTION, AND ELEVATED METAL ION LEVELS. IT IS ALLEGED THAT THE PATIENT UNDERWENT MULTIPLE REVISIONS ON UNKNOWN DATES. LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT REVISION PROCEDURES ON UNKNOWN DATES. REVIEW OF INVOICE HISTORY INDICATES THE LEFT TOTAL HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2012. 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
    290044 28MM DIA COCR MOD HD STD NK PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 476200

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R