BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN, HIP

    MDR report key: 4638878 · Received March 27, 2015

    Report

    Report Number
    0001825034-2015-01202
    Event Type
    Death
    Date Received
    March 27, 2015
    Report Date
    March 31, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE PATIENTS MENTIONED IN THE JOURNAL ARTICLE. (B)(6). IT IS LIKELY THAT THESE COMPLICATIONS AND REVISIONS HAVE ALREADY BEEN REPORTED; HOWEVER, IT CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION MADE AVAILABLE IN THE ARTICLE. SHOULD ADDITIONAL INFORMATION RELATING TO THE EVENTS BE RECEIVED, THE UPDATED INFORMATION WILL BE FORWARDED TO THE FDA.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY THAT THE PATIENTS REFERENCED IN THE JOURNAL ARTICLE ASSOCIATED WITH THIS MANUFACTURER REPORT NUMBER ARE IN THE SAME STUDY GROUP OF PATIENTS REFERENCED IN THE JOURNAL ARTICLE ASSOCIATED WITH 1825034-2014-09094.

    Description of Event or Problem · 1

    INFORMATION WAS REVIEWED BASED ON A JOURNAL ARTICLE TITLED "VITAMIN-E DIFFUSED HIGHLY CROSS-LINKED POLYETHYLENE LINER COMPARED TO STANDARD LINERS IN TOTAL HIP ARTHROPLASTY. A RANDOMIZED, CONTROLLED TRIAL". THIS STUDY HYPOTHESIZED THAT A VITAMIN E-TREATED POLYETHYLENE ARTICULATING LINER HAD LOWER FEMORAL HEAD PENETRATION THAN A CONVENTIONAL LINER USING A REGENEREX SHELL, E1 LINER MANUFACTURED AT BIOMET. THE STUDY CONSISTED OF FIFTY-ONE PATIENTS WITH PRIMARY HIP OSTEOARTHRITIS BETWEEN OCTOBER 2009 AND AUGUST 2013. THE HEAD PENETRATION IN X- (MEDIAL/LATERAL) AND Y- (VERTICAL) AXES WAS SIGNIFICANTLY LOWER FOR THE VITAMIN E-TREATED LINER UP TO TWO YEARS WITH A MEAN DIFFERENCE BETWEEN THE GROUPS OF .10 MM AND .08 MM RESPECTIVELY. THE INITIAL TOTAL PENETRATION WAS LOWER FOR THE VITAMIN-E GROUP BUT DID NOT REACH STATISTICAL SIGNIFICANCE AT TWO YEARS WITH A MEAN DIFFERENCE BETWEEN THE GROUPS OF .07 MM. ONE PATIENT IN THE CONTROL GROUP SUFFERED A CALCAR FEMORAL FRACTURE THREE WEEKS POSTOPERATIVELY, AND THE STEM WAS REVISED BUT THE ACETABULAR COMPONENT AND LINER WERE LEFT IN SITU. ONE PATIENT IN THE TREATMENT GROUP HAD INCREASING HIP PAIN STARTING SEVERAL MONTHS AFTER SURGERY. RADIOLUCENT LINES WERE VISIBLE ALONG THE STEM BUT NOT BEHIND THE CUP. DURING REVISION SURGERY, A LOW VIRULENT DEEP PERIPROSTHETIC INFECTION COULD BE VERIFIED. THERE WERE THE FOLLOWING ADVERSE EVENTS RELATED TO BIOMET PRODUCTS: PERIPROSTHETIC INFECTION - 1 VITAMIN E GROUP, LATERAL THIGH PAIN - 4 VITAMIN E GROUP, LEG LENGTH DISCREPANCY - 2 VITAMIN E GROUP, LOW BACK PAIN - 4 VITAMIN E GROUP, PAIN, CONTRALATERAL HIP - 4 VITAMIN E GROUP, KNEE PAIN - 4 VITAMIN E GROUP, ISCHIALGIA - 2 VITAMIN E GROUP, MALIGNANCY - 2 VITAMIN E GROUP, DECEASED - 1 VITAMIN E GROUP. THERE WERE TWO DEATHS REPORTED. THE DEATH OF THE PATIENT IMPLANTED WITH BIOMET PRODUCTS IS STATED TO BE UNRELATED TO THE PROCEDURE. IN CONCLUSION, THE NEW VITAMIN-E DIFFUSED HXLPE LINER, COMPARED TO A CONVENTIONAL HXLPE LINER, THE VITAMIN-E DIFFUSED LINER WAS FOUND LOWER INITIAL HEAD PENETRATION AND LOWER SUPERIOR AND MEDIAL WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206036 UNKNOWN, HIP PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R