BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC MICROP LAT FMRL 25.0M

    MDR report key: 3677794 · Received March 13, 2014

    Report

    Report Number
    0001825034-2014-01697
    Event Type
    Injury
    Date Received
    March 13, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK062994
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    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 DUE TO THE PART/LOT INFORMATION COULD BE: CATEGORY NUMBER ¿ 14-103212; LOT NUMBER - 762050; EXPIRATION DATE ¿ MAY 31, 2018; MANUFACTURE DATE ¿ MAY 23, 2008. OR THE PART/LOT INFORMATION COULD BE: CATEGORY NUMBER ¿ 15-103212; LOT NUMBER - 563830; EXPIRATION DATE ¿ OCTOBER 31, 2017; MANUFACTURE DATE ¿ OCTOBER 8, 2007. DATE OF EVENT - UNKNOWN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 6 OF 6 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-01565/01569, 01697).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT ALLEGES PATIENT UNDERWENT A BILATERAL TOTAL HIP ARTHROPLASTY ON (B)(6), 2008. SUBSEQUENTLY, LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION AND METALLOSIS. LEGAL COUNSEL FURTHER REPORTS A RIGHT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2013 AND A LEFT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2013. REVIEW OF INVOICE HISTORY INDICATES THE HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED ON (B)(6), 2013. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT LEFT HIP REVISION PROCEDURE PERFORMED ON (B)(6), 2013 NOTED LOCAL TISSUE STAINING CONSISTENT WITH METALLOSIS; FLUID AND EVIDENCE OF TRUNNIONOSIS. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATE PATIENT'S BLOOD TEST RESULTS. 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 ALLEGES PATIENT UNDERWENT A BILATERAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, DISCOMFORT, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION AND METALLOSIS. LEGAL COUNSEL FURTHER REPORTS A RIGHT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 AND A LEFT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013. REVIEW OF INVOICE HISTORY INDICATES THE HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED ON (B)(6) 2013. 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
    150832 TAPERLOC MICROP LAT FMRL 25.0M PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R