BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-TAPER LINER SZ 41/32

    MDR report key: 3790543 · Received May 5, 2014

    Report

    Report Number
    0001825034-2014-03557
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    August 3, 2010
    Report Date
    June 7, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWY
    PMA / PMN Number
    PK003363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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, "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 3 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-03555 / 03559).

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL. THIS REPORT IS NUMBER 3 OF 6 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-03555 /- 03556 /-03557 /-03558 /-03559 /-05632).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, BONE/TISSUE DAMAGE, IMPLANT CLICKING AND METALLOSIS. LEGAL COUNSEL INDICATED THAT A SECOND REVISION PROCEDURE OCCURRED ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF DISLOCATIONS. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE AND BOTH REVISION SURGERIES. INVOICE HISTORY INDICATES THE ACETABULAR CUPS, LINERS AND MODULAR HEADS WERE REMOVED AND REPLACED DURING BOTH REVISION PROCEDURES. 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

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010 DUE TO PATIENT ALLEGATIONS OF PAIN, LOSS OF RANGE OF MOTION, BONE/TISSUE DAMAGE, IMPLANT CLICKING AND METALLOSIS. LEGAL COUNSEL INDICATED THAT A SECOND REVISION PROCEDURE OCCURRED ON (B)(6) 2011 DUE TO PATIENT ALLEGATIONS OF DISLOCATIONS. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE AND BOTH REVISION SURGERIES. INVOICE HISTORY INDICATES THE ACETABULAR CUPS, LINERS AND MODULAR HEADS WERE REMOVED AND REPLACED DURING BOTH REVISION PROCEDURES. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN THE (B)(6) 2010 RIGHT HIP REVISION REPORT NOTED THE REVISION WAS DUE TO DISLOCATION. OPERATIVE REPORT FURTHER NOTED THE PRESENCE OF A SINUS CONTAINING METALLOSIS, JOINT FLUID, METALLOSIS, GRANULATION TISSUE, HYPERTROPHIC CAPSULE, A CENTRAL DEFECT, AND OSTEOLYSIS PRODUCING A CAVITY. THE MODULAR HEAD, ACETABULAR CUP AND LINER WERE REMOVED AND REPLACED. AN ADDITIONAL RIGHT HIP REVISION WAS PERFORMED ON (B)(6) 2011. THE OPERATIVE REPORT NOTED THE PRESENCE OF A FLUID COLLECTION, DISCOLORATION OF SOFT TISSUES CONSISTENT WITH METALLOSIS, A FLUID SAC, NECROTIC TISSUE, GRANULATION TISSUE, FIBROUS TISSUE, SCAR TISSUE, ACETABULAR DEFECTS, AND MICROMOTION IN THE ACETABULAR CUP. THE MODULAR HEAD, ACETABULAR CUP AND LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268280 M2A-TAPER LINER SZ 41/32 PROSTHESIS, HIP KWY BIOMET ORTHOPEDICS N/A 171190

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R