BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM MOD HEAD COCR -6MM NECK

    MDR report key: 3970533 · Received July 31, 2014

    Report

    Report Number
    0001825034-2014-06641
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    November 13, 2013
    Report Date
    November 4, 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
    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, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    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. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-06641 AND 08740).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, LACK OF MOBILITY, DAMAGE TO BONE/TISSUE, METAL POISONING, METALLOSIS AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE. A REVIEW OF THE INVOICE HISTORY INDICATES PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6), 2013 AND A REVISION PROCEDURE ON (B)(6), 2013. IT FURTHER SUGGESTS ALL COMPONENTS WERE REMOVED AND REPLACED DURING THE REVISION PROCEDURE. 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 PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, LACK OF MOBILITY, DAMAGE TO BONE/TISSUE, METAL POISONING, METALLOSIS AND ELEVATED METAL ION LEVELS. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE. A REVIEW OF THE INVOICE HISTORY INDICATES PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2013 AND A REVISION PROCEDURE ON (B)(6) 2013. IT FURTHER SUGGESTS ALL COMPONENTS WERE REMOVED AND REPLACED DURING THE REVISION PROCEDURE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEALED THE PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S MEDICAL RECORDS REVEALED THE (B)(6) 2013 REVISION WAS DUE TO AN UNSTABLE LEFT HIP. THE PATIENT'S OPERATIVE REPORT NOTED THE HEAD AND ACETABULAR LINER WAS REMOVED AND REPLACED. THE IMPLANT PRODUCT IDENTIFICATION AND REVIEW OF INVOICE HISTORY ONLY SHOWED THE ACETABULAR LINER IMPLANT. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S MEDICAL RECORDS REVEALED A SECOND LEFT HIP REVISION SURGERY PERFORMED ON (B)(6) 2014 DUE TO AN UNSTABLE HIP. THE PATIENT'S OPERATIVE REPORT NOTED THE HEAD, LOCKING RING, AND ACETABULAR LINER WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448068 32MM MOD HEAD COCR -6MM NECK PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 124020

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R