BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW

    MDR report key: 3897173 · Received June 26, 2014

    Report

    Report Number
    0001825034-2014-05771
    Event Type
    Injury
    Date Received
    June 26, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK991807
    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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - N/A. DATE EXPLANTED - N/A. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO PRODUCTS REPORTED TO HAVE BEEN REMOVED ON TWO SEPARATE DATES. IT CANNOT BE DETERMINED WHICH SEVEN OF THE FOLLOWING EIGHT INDIVIDUAL PRODUCTS WERE REMOVED DURING THE (B)(6) 2008 PROCEDURE AND WHICH ONE WAS REMOVED DURING THE (B)(6) 2007 PROCEDURE: CATALOGUE NUMBER: 103534, LOT: 940070, EXPIRATION DATE: JUNE 30, 2017, MANUFACTURE DATE: JUNE 8, 2007. CATALOGUE NUMBER: 103533, LOT: 927890, EXPIRATION DATE: JUNE 30, 2017, MANUFACTURE DATE: JUNE 8, 2007. CATALOGUE NUMBER: 103531, LOT: 217980, EXPIRATION DATE: OCTOBER 31, 2014, MANUFACTURE DATE: OCTOBER 6, 2004. CATALOGUE NUMBER: 103530, LOT: 778470, EXPIRATION DATE: JANUARY 31, 2011, MANUFACTURE DATE: JANUARY 10, 2001. CATALOGUE NUMBER: 103531 LOT: 688110, EXPIRATION DATE: MAY 31, 2017, MANUFACTURE DATE: MAY 2, 2007. CATALOGUE NUMBER: 103531 LOT: 104950, EXPIRATION DATE: JANUARY 31, 2017, MANUFACTURE DATE: JANUARY 31, 2007. CATALOGUE NUMBER: 103532 LOT: 785980, EXPIRATION DATE: JUNE 30, 2017, MANUFACTURE DATE: JUNE 12, 2007 CATALOGUE NUMBER: 103532 LOT: 864880, EXPIRATION DATE: JUNE 30, 2017, MANUFACTURE DATE: JUNE 6, 2007. THE REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE HAS OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. THIS REPORT IS NUMBER 19 OF 19 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-02587 / -02596, -02599 / -02606 & -05771).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT HIP REVISION SURGERY ON (B)(6) 2007, (B)(6) 2008, DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, DYSFUNCTION, LOSS OF RANGE OF MOTION, METAL POISONING, METALLOSIS, AND ELEVATED METAL IONS. LEGAL COUNSEL FURTHER REPORTED AN INITIAL RIGHT HIP ARTHROPLASTY PROCEDURE ON (B)(6) 2010. A REVIEW OF INVOICE HISTORY CONFIRMED THE ABOVE REFERENCED DATES. ADDITIONALLY, INVOICE HISTORY REVIEW SHOWS INITIAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2006, AND A REVISION PROCEDURE ON (B)(6) 2008. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT¿S OPERATIVE (OP) NOTES DATED (B)(6) 2007 REPORTS PATIENT WAS REVISED ON THE LEFT HIP FOR LEFT PROTRUSIO ACETABULI SECONDARY TO BIPOLAR ENDOPROSTHESIS AND OPEN REDUCTION INTERNAL FIXATION POSTERIOR COLUMN FRACTURE. REVISION OP REPORT NOTES PRESENCE OF CLOUDY FLUID, BLOODY FLUID, AND A POSTERIOR COLUMN FRACTURE. THE HEAD WAS REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT¿S OP NOTES DATED (B)(6) 2007 REPORTS PATIENT WAS REVISED ON THE LEFT HIP DUE TO RECURRENT DISLOCATION. REVISION OP REPORT NOTES PRESENCE OF A HEMATOMA AND THAT THE POSTERIOR STRUCTURES HAD RUPTURED DURING A RECENT DISLOCATION. THE MODULAR CUP AND HEAD WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT¿S OP NOTES DATED (B)(6) 2008 REPORTS PATIENT WAS REVISED ON THE LEFT HIP DUE TO A DISPLACED LEFT CONSTRAINED TOTAL HIP COMPONENT AND INFECTION. REVISION OP REPORT NOTES PRESENCE OF A BULGING SCAR AND ERYTHEMATOUS SCAR MATERIAL THAT HAD A PURULENT AND NECROTIC APPEARANCE. ALL LEFT HIP COMPONENTS WERE REMOVED REPLACED WITH ANTIBIOTIC SPACERS. DURING THE SECOND STAGE OF THE REVISION, DATED (B)(6) 2008, OP REPORT NOTES THE PRESENCE OF STRAW-COLORED FLUID AND SCARRING WITH SHORTENING OF THE MUSCULATURE. OP REPORT FURTHER NOTES THAT THE PROCEDURE TOOK 5 HOURS COMPARED TO THE EXPECTED 2 TO 2.5 HOUR COMPLETION TIME. THERE HAS BEEN NO REPORTED REVISION PROCEDURE FOR THE RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373433 TI LOW PROFILE SCREW PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R