BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 5351963 · Received January 7, 2016

    Report

    Report Number
    0001825034-2016-00088
    Event Type
    Injury
    Date Received
    January 7, 2016
    Report Date
    October 27, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 PATIENT MENTIONED IN THE JOURNAL ARTICLE. THE ARTICLE WAS WRITTEN BY JEFFREY R. MCLAUGHLIN AND KYLA R. LEE.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE HE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "TOTAL HIP ARTHROPLASTY WITH AN UNCEMENTED TAPERED FEMORAL COMPONENT IN PATIENTS YOUNGER THAN FIFTY YEARS OF AGE: A MINIMUM TWENTY YEAR FOLLOW-UP STUDY" WHICH AIMED TO UPDATE A PREVIOUS REPORT USING THE TAPERLOC FEMORAL COMPONENT IN YOUNG PATIENTS WHO HAD BEEN FOLLOWED FOR A MINIMUM OF 20 YEARS POST OPERATIVELY. BETWEEN 1983 AND 1990, 108 CONSECUTIVE UNCEMENTED TOTAL HIP ARTHROPLASTIES WERE PERFORMED IN 91 PATIENTS LESS THAN 50 YEARS OF AGE, WITH USE OF THE TAPERLOC FEMORAL COMPONENT. FIFTEEN PATIENTS (17 HIPS) DIED PRIOR TO OBTAINING A MINIMUM 20 YEAR FOLLOW-UP DUE TO UNKNOWN REASONS. NINE FEMORAL COMPONENTS UNDERWENT REVISION SURGERY. FIVE WELL FIXED STEMS WERE REMOVED DURING ACETABULAR REVISION, THREE STEMS WERE REVISED FOR INFECTION AND ONE STEM WAS EXCHANGED BECAUSE OF PERONEAL NERVE PALSY. IN CONCLUSION, PRIMARY TOTAL HIP ARTHROPLASTY WITH THE TAPERLOC FEMORAL COMPONENT IN YOUNG PATIENTS WAS ASSOCIATED WITH A HIGH RATE OF SURVIVAL AT 29 YEARS.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "TOTAL HIP ARTHROPLASTY WITH AN UNCEMENTED TAPERED FEMORAL COMPONENT IN PATIENTS YOUNGER THAN FIFTY YEARS OF AGE: A MINIMUM TWENTY YEAR FOLLOW-UP STUDY" WHICH AIMED TO UPDATE A PREVIOUS REPORT USING THE TAPERLOC FEMORAL COMPONENT IN YOUNG PATIENTS WHO HAD BEEN FOLLOWED FOR A MINIMUM OF 20 YEARS POST OPERATIVELY. BETWEEN 1983 AND 1990, 108 CONSECUTIVE UNCEMENTED TOTAL HIP ARTHROPLASTIES WERE PERFORMED IN 91 PATIENTS LESS THAN 50 YEARS OF AGE, WITH USE OF THE TAPERLOC FEMORAL COMPONENT. TWELVE PATIENTS (14 HIPS) DIED PRIOR TO OBTAINING A MINIMUM 11 YEAR FOLLOW-UP DUE TO UNKNOWN REASONS. THREE FEMORAL COMPONENTS AND FIFTY-NINE ACETABULAR COMPONENTS UNDERWENT REVISION SURGERY. ONE WELL-FIXED FEMORAL COMPONENT WAS REVISED DURING ACETABULAR REVISION 10 YEARS POSTOPERATIVELY. ONE PATIENT WAS REVISED FOR SEPSIS AT 9.5 YEARS POSTOPERATIVELY. THIS WAS TREATED WITH AN EXPLANTATION OF BOTH COMPONENTS DURING WHICH THE FEMORAL COMPONENT WAS FOUND TO BE WELL FIXED. ONE FEMORAL COMPONENT WAS REVISED IMMEDIATELY POSTOPERATIVE BECAUSE OF PERONEAL NERVE PALSY SECONDARY TO EXCESSIVE LEG LENGTHENING. FIFTY-EIGHT ACETABULAR COMPONENTS WERE REVISED FOR ASEPTIC LOOSING. FIVE PATIENTS (5 HIPS) HAD PAIN SECONDARY TO A LOOSE ACETABULAR COMPONENT AND THIGH PAIN WAS PRESENT IN 2 HIPS. TWO PATIENTS DEVELOPED PULMONARY EMBOLI; BOTH WERE TREATED MEDICALLY WITHOUT SEQUEL. IN CONCLUSION, PRIMARY TOTAL HIP ARTHROPLASTY WITH THE TAPERLOC FEMORAL COMPONENT IS A RELIABLE STEM IN YOUNG PATIENTS REQUIRING PRIMARY TOTAL HIP ARTHROPLASTY.

    Description of Event or Problem · 1

    IN FIVE HIPS, A WELL FIXED FEMORAL COMPONENT WAS REVISED DURING ACETABULAR REVISION, POST THR. THE FEMORAL COMPONENT WAS REMOVED BECAUSE THE NON-MODULAR HEAD OBSTRUCTED ACETABULAR EXPOSURE. PATIENT OUTCOME FOLLOWING ACETABULAR REVISION WAS RESULTED AS INSTABILITY OF THE HIP. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9160 UNKNOWN HIP PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R