BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIA COCR MOD HD STD NK

    MDR report key: 3191271 · Received June 26, 2013

    Report

    Report Number
    0001825034-2013-02263
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    February 23, 2012
    Report Date
    January 20, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 4 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02132-1/02133-1 AND 2013-02262 / 02264).

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CORRECTION: THE REPORT THAT "PATIENT UNDERWENT A REVISION ON THE LEFT HIP ON (B)(6) 2012," WAS MADE IN ERROR AND HAS BEEN CORRECTED IN THIS REPORT. THIS REPORT IS NUMBER 4 OF 6 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02132-1/-02133-1 & -2013-02262 / -02264 & -2015-00410).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS PATIENT UNDERWENT LEFT HIP ARTHROPLASTY ON (B)(6) 2003 AND RIGHT HIP ARTHROPLASTY ON (B)(6) 2003. FURTHER, INVOICE HISTORY REVEALED A REVISION PROCEDURE TOOK PLACE ON (B)(6) 2012; HOWEVER, IT IS NOT KNOWN WHICH HIP WAS REVISED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012 ,WAS FOR THE RIGHT HIP AND DUE TO PAIN AND METAL ON METAL HYPERSENSITIVITY. THE OPERATIVE NOTES CONFIRM THAT THE MODULAR HEAD WAS REMOVED AND REPLACED. SUBSEQUENTLY, PATIENT UNDERWENT A SECOND REVISION OF THE RIGHT HIP ON (B)(6) 2012, DUE TO INFECTION. THE OPERATIVE NOTES CONFIRM THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED. PATIENT UNDERWENT A REVISION ON THE LEFT HIP ON (B)(6), 2012 AND A THIRD REVISION OF THE RIGHT HIP ON (B)(6) 2013, DUE TO UNKNOWN REASONS. 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 THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS PATIENT UNDERWENT LEFT HIP ARTHROPLASTY ON (B)(6) 2003 AND RIGHT HIP ARTHROPLASTY ON (B)(6), 2003. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012 WAS FOR THE RIGHT HIP AND DUE TO PAIN AND METAL ON METAL HYPERSENSITIVITY. THE OPERATIVE (OP) NOTES CONFIRM THAT THE MODULAR HEAD WAS REMOVED AND REPLACED. SUBSEQUENTLY, PATIENT UNDERWENT A SECOND REVISION OF THE RIGHT HIP ON (B)(6) 2012 DUE TO INFECTION. THE OPERATIVE NOTES CONFIRM THE MODULAR HEAD AND LINER WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT OPERATIVE (OP) REPORT DATED (B)(6) 2012 NOTES THE PRESENCE OF FIBRINOUS MATERIAL AND REACTIVE TISSUE. OP REPORT DATED (B)(6) 2012 NOTES PURULENT FLUID, DEVITALIZED TISSUE, LITTLE EVIDENCE OF HEALING AROUND THE CAPSULAR TEAR, AND EVIDENCE THAT THE SUTURES HAD BEEN PULLED OUT FROM THE CAPSULE. ADDITIONAL OP NOTES DATED (B)(6) 2012 AND (B)(6) 2013 REPORT A 2-STAGE REVISION DUE TO INFECTION. ALL COMPONENTS WERE REMOVED (B)(6) 2012 AND REPLACED (B)(6) 2013. FLUID WAS NOTED DURING BOTH PROCEDURES. SUBSEQUENTLY, OP REPORT DATED (B)(6) 2013 REPORTS A REVISION PROCEDURE DUE TO PAIN AND A LOOSE RIGHT FEMORAL COMPONENT WITH SUBSIDENCE. PATIENT MEDICAL RECORDS REPORT ALL REVISION PROCEDURES ARE FOR THE RIGHT HIP. THERE HAVE BEEN NO MEDICAL RECORDS RECEIVED, TO DATE, TO INDICATE A LEFT REVISION PROCEDURE HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290836 28MM DIA COCR MOD HD STD NK PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 084480

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R