BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW 6.5X20MM

    MDR report key: 3438326 · Received October 30, 2013

    Report

    Report Number
    0001825034-2013-04943
    Event Type
    Injury
    Date Received
    October 30, 2013
    Date of Event
    June 10, 2009
    Report Date
    September 21, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK991807
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    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 NUMBER 7 OF 16 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-04937 / 04952).

    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 7 OF 21 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-04937 / 04952 & 2014-02821 / 02825).

    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 7 OF 21 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-04937 / 04952 & 2014-02821 / 02825).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2004 SUBSEQUENTLY, PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2006 DUE TO A LOOSE CUSTOM ACETABULAR CUP AND HEMATOMA. THE ACETABULAR CUP, MODULAR HEAD AND SCREWS WERE REMOVED AND REPLACED WITH A MODULAR HEAD AND ANTIBIOTIC MOLDS. PATIENT UNDERWENT REIMPLANTATION ON (B)(6) 2007 DUE TO INFECTION. THE MODULAR HEAD AND ANTIBIOTIC SPACERS WERE REMOVED AND REPLACED WITH A CUSTOM ACETABULAR CUP, MODULAR HEAD AND LINER. PATIENT UNDERWENT A SECOND REVISION ON (B)(6) 2009 DUE TO RECURRED INFECTION. THE MODULAR HEAD WAS REMOVED AND REPLACED. PATIENT FURTHER UNDERWENT A GIRDLESTONE PROCEDURE ON (B)(6) 2010 DUE TO RECURRED HEMATOMA. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A TOTAL RIGHT HIP ARTHROPLASTY ON AN UNKNOWN DATE IN 1977. PATIENT UNDERWENT A REVISION PROCEDURE ON OCTOBER 20, 1988 FOR UNKNOWN REASONS. SUBSEQUENTLY, PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE ON NOVEMBER 10, 1988. IT WAS FURTHER REPORTED PATIENT UNDERWENT A REVISION ON DECEMBER 28, 1988 DUE TO UNKNOWN REASONS. PATIENT UNDERWENT AN ACETABULAR CUP REVISION ON FEBRUARY 22, 1989 FOR UNKNOWN REASONS. SUBSEQUENTLY, PATIENT UNDERWENT REVISION PROCEDURES ON JUNE 1, 1995 AND JULY 2, 1998 FOR UNKNOWN REASONS. IT WAS FURTHER REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ON NOVEMBER 3, 2004 DUE TO ACETABULAR CUP LOOSENING. SUBSEQUENTLY, PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE ON SEPTEMBER 11, 2006 DUE TO A LOOSE CUSTOM ACETABULAR CUP, HEMATOMA AND POSSIBLE INFECTION. THE ACETABULAR CUP, MODULAR HEAD AND SCREWS WERE REMOVED AND REPLACED WITH A MODULAR HEAD AND ANTIBIOTIC MOLDS. PATIENT UNDERWENT A REVISION ON JUNE 10, 2009 DUE TO RECURRENT INFECTION AND PELVIC HIP FRACTURE. PATIENT FURTHER UNDERWENT A GIRDLESTONE PROCEDURE ON (B)(6) 2010 DUE TO RECURRENT HEMATOMA.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A TOTAL RIGHT HIP ARTHROPLASTY ON AN UNKNOWN DATE IN 1977. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 1988 FOR UNKNOWN REASONS. SUBSEQUENTLY, PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE ON (B)(6) 1988. IT WAS FURTHER REPORTED PATIENT UNDERWENT A REVISION ON (B)(6) 1988 DUE TO UNKNOWN REASONS. PATIENT UNDERWENT AN ACETABULAR CUP REVISION ON (B)(6) 1989 FOR UNKNOWN REASONS. SUBSEQUENTLY, PATIENT UNDERWENT REVISION PROCEDURES ON (B)(6)1995 AND (B)(6) 1998 FOR UNKNOWN REASONS. IT WAS FURTHER REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2004 DUE TO CUP MIGRATION AND FRACTURED FLANGE. SUBSEQUENTLY, THE PATIENT RETURNED FOR FOLLOW-UP EXPERIENCING PAIN, DISCOMFORT, AND A MASS EFFECT ABOUT THE HIP. THE MASS WAS ASPIRATED AND DETERMINED TO BE FLUID OR AN ORGANIZED TYPE OF HEMATOMA. SUBSEQUENTLY, PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2006 DUE TO A LOOSE CUSTOM ACETABULAR CUP, HEMATOMA AND POSSIBLE INFECTION. THE ACETABULAR CUP, MODULAR HEAD AND SCREWS WERE REMOVED AND REPLACED WITH A MODULAR HEAD AND ANTIBIOTIC MOLDS. PATIENT UNDERWENT REIMPLANTATION ON (B)(6) 2007 DUE TO INFECTION. THE MODULAR HEAD AND ANTIBIOTIC SPACERS WERE REMOVED AND REPLACED WITH A CUSTOM ACETABULAR CUP, MODULAR HEAD AND LINER. PATIENT UNDERWENT A REVISION ON (B)(6) 2009 DUE TO RECURRENT INFECTION AND PELVIC HIP FRACTURE. PATIENT FURTHER UNDERWENT A GIRDLESTONE PROCEDURE ON (B)(6) 2010 DUE TO RECURRENT HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556419 TI LOW PROFILE SCREW 6.5X20MM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 810490

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R