BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN HIP

    MDR report key: 5091854 · Received September 21, 2015

    Report

    Report Number
    0001825034-2015-04029
    Event Type
    Death
    Date Received
    September 21, 2015
    Report Date
    November 14, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    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 PATIENTS MENTIONED IN THE JOURNAL ARTICLE. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY MCLAUGHLIN ET AL IN THE JOURNAL OF ARTHROPLASTY (2014), DOI: 10.1016/J.ARTH.2014.02.019.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO ADDRESS ONLY ONE EVENT OF THE ARTICLE. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/ UPDATED INFORMATION. THE PRODUCT WAS NOT RETURNED FOR EVALUATION DUE TO UNKNOWN LOCATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD (DHR) AND COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT/ITEM NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE 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, UNDER POSSIBLE ADVERSE EFFECTS: "IMPLANTS CAN LOOSEN OR MIGRATE DUE TO TRAUMA OR LOSS OF FIXATION" AND "FRACTURE OF THE FEMUR CAN OCCUR WHILE PRESS-FITTING THE FEMORAL STEM COMPONENT INTO THE PREPARED FEMORAL CANAL". FOLLOWING REVIEW, NO NEW RISKS WERE IDENTIFIED. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE ENTITLED, "UNCEMENTED TOTAL HIP ARTHROPLASTY USING A TAPERED FEMORAL COMPONENT IN OBESE PATIENTS: AN 18-27 YEAR FOLLOW-UP STUDY." THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE EFFICACY OF AN UNCEMENTED TAPERED FEMORAL COMPONENT IN OBESE PATIENTS AT A MEAN FOLLOW-UP OF 23 YEARS. THIS STUDY RETROSPECTIVELY REVIEWED 119 CONSECUTIVE UNCEMENTED TOTAL HIP ARTHROPLASTIES IN 105 OBESE PATIENTS USING A TAPERED FEMORAL COMPONENT BETWEEN 1983 AND 1987. THE MEAN BODY MASS INDEX OF THESE PATIENTS WAS 34 (RANGE 30-47). COMPLETE CLINICAL AND RADIOGRAPHIC FOLLOW-UP WAS OBTAINED ON THE 55 HIPS IN 47 PATIENTS WHO SURVIVED A MINIMUM OF 18 YEARS (RANGE 18-27 YEARS). THREE FEMORAL COMPONENTS (6%) HAVE BEEN REVISED, NONE FOR ASEPTIC LOOSENING. ONE WAS LOOSE BY RADIOGRAPHIC CRITERIA. THESE RESULTS DEMONSTRATE THAT AN UNCEMENTED TAPERED STEM CAN PROVIDE EXCELLENT FIXATION IN OBESE PATIENTS OUT TO 27 YEARS. THE INCIDENCE OF ASEPTIC LOOSENING AND REVISION HAS RANGED FROM 0% TO 9 % IN SEVERAL PUBLISHED SERIES AT GREATER THAN TEN YEARS FOLLOW UP. THESE REPORTS HAVE INCLUDED DIVERSE PATIENT GROUPS INCLUDING OLD YOUNG AND ACTIVE PATIENTS. THE SUCCESS OF TAPERED FEMORAL COMPONENTS HAS INEVITABLY LED TO THEIR USE IN OBESE PATIENTS. THESE RESULTS ARE FROM USING THE TAPERLOC FEMORAL COMPONENT (BIOMET, (B)(4)) IN OBESE AND MORBIDLY OBESE PATIENTS. IN 2004, THE UNITED STATES CENTERS FOR DISEASE CONTROL AND PREVENTION REPORTED THAT 65% OF THE AMERICAN PEOPLE WERE OVERWEIGHT AND 31% WERE OBESE. THE QUESTION REMAINS WHETHER THE EXCELLENT RESULTS REPORTED USING A TAPERED FEMORAL COMPONENT, IN OBESE PATIENTS, AT MID-TERM FOLLOW UP WILL CONTINUE AT LONG-TERM WITH RESULTS AT 18-27 YEARS USING THE TAPERLOC FEMORAL COMPONENT IN OBESE AND MORBIDLY OBESE PATIENTS. BETWEEN SEPTEMBER 1983 AND JUNE 1987, ONE HUNDRED AND NINETEEN CONSECUTIVE PRIMARY TOTAL HIP ARTHROPLASTIES WERE PERFORMED ON 105 OBESE PATIENTS BY A SINGLE SURGEON. NONE OF THE ORIGINAL COHORT OF 105 PATIENTS (119 HIPS) WAS LOST TO FOLLOW UP. BEFORE OBTAINING A MINIMAL 18 YEAR FOLLOW-UP FIFTY-EIGHT PATIENTS (64 HIPS) HAD DIED. FIFTY-THREE PATIENTS (59 HIPS) (92%) DIED WITH THEIR FEMORAL COMPONENT IN PLACE. IN TWO PATIENTS (2 HIPS) A WELL FIXED FEMORAL COMPONENT WAS REVISED DURING ACETABULAR REVISION. TWO WELL-FIXED FEMORAL COMPONENTS WERE REVISED FOR LATE SEPSIS, AND ONE STEM WAS REVISED FOR LOOSENING. FORTY-SEVEN PATIENTS (55 HIPS) SURVIVED FOR A MINIMUM OF EIGHTEEN YEARS POST INDEX PROCEDURE. THREE PATIENTS (3 HIPS) (6%) HAVE UNDERGONE FEMORAL COMPONENT REVISION. THE REMAINING FORTY-FOUR PATIENTS (52 HIPS) HAVE BEEN FOLLOWED FOR AN AVERAGE OF 23 YEARS (RANGE 18-27 YEARS). THERE WERE 17 WOMEN (19 HIPS) AND 27 MEN (33 HIPS). THE MEAN AGE OF THE PATIENTS AT THE TIME OF OPERATION WAS 44 YEARS (RANGE 20-74). THE MEAN BMI OF THE PATIENTS AT THE TIME OF INDEX PROCEDURE WAS 34 (RANGE 30-47). RESULTS AT THE TIME OF LATEST FOLLOW-UP, AT A MINIMUM OF EIGHTEEN YEARS, FORTY SEVEN PATIENTS (55 HIPS) WERE STILL LIVING AND FIFTY-EIGHT PATIENTS (64 HIPS) HAD DIED. OF THE ORIGINAL COHORT OF 119 HIPS, EIGHT STEMS (7%) HAD BEEN REVISED, ONLY ONE (1%) FOR ASEPTIC LOOSENING. IN FOUR HIPS, (3%) A WELL FIXED FEMORAL COMPONENT WAS REVISED DURING ACETABULAR REVISION. THREE WELL FIXED STEMS (3%) WERE REMOVED FOR LATE SEPSIS. FIFTY-EIGHT PATIENTS (64 HIPS) DIED PRIOR TO ACHIEVING THE MINIMUM EIGHTEEN YEAR FOLLOW UP FOR THIS REVIEW. OF THESE FIVE (8%) FEMORAL COMPONENTS HAD BEEN REVISED. TWO (3%) WELL-FIXED FEMORAL COMPONENTS WERE REMOVED DURING ACETABULAR REVISION AT 5 AND 8 YEARS POSTOPERATIVELY. TWO (3%) FEMORAL COMPONENTS WERE REVISED FOR LATE SEPSIS AT 7 AND 10 YEARS. THE ONE (2%) FEMORAL COMPONENT REVISED FOR ASEPTIC LOOSENING WAS REVISED AT 10 MONTHS POST OPERATIVELY. THE STEM WAS REVISED SECONDARY TO AN UNRECOGNIZED INTRAOPERATIVE CALCAR FRACTURE. THIS STEM SUBSIDED 2 CM AND WAS FOUND TO BE GROSSLY LOOSE AT THE TIME OF REVISION SURGERY. OF THE 105 PATIENTS (119 HIPS), FORTY-SEVEN PATIENTS (55 HIPS) WERE ALIVE AT AN AVERAGE FOLLOW-UP OF 23 YEARS (RANGE, 18 TO 27 YEARS). FIFTY TWO STEMS REMAINED IN SITU AND THREE (6%) HAD BEEN REVISED, NONE FOR ASEPTIC LOOSENING. TWO (4%) FEMORAL COMPONENTS WERE REMOVED DURING ACETABULAR REVISION AT 7 AND 18 YEARS. ONE (2%) STEM WAS REVISED FOR SEPSIS AT 12 YEARS. ALL THREE OF THESE STEMS WERE FOUND TO BE WELL FIXED AT THE TIME OF REVISION SURGERY. AND THIGH PAIN WAS PRESENT IN 2 HIPS (4%). FIFTY-ONE FEMORAL COMPONENTS (98%) WERE RATED AS HAVING FIXATION BY BONE INGROWTH. ONE HIP (2%) WAS JUDGED LOOSE BY RADIOGRAPHIC CRITERIA. WITH THE NUMBERS AVAILABLE, THERE WAS NO ASSOCIATION BETWEEN FEMORAL COMPONENT LOOSENING AND AGE, OR GENDER. A POSTOPERATIVE COMPLICATION OCCURRED IN ONE PATIENT (2%)(TABLE 1). THIS PATIENT DEVELOPED A DEEP VEIN THROMBOSIS WHICH WAS TREATED MEDICALLY AND RESOLVED WITHOUT SEQUELA. NO PATIENT HAD A POSTOPERATIVE DISLOCATION AND NO PATIENT REQUIRED RE-ADMISSION FOR A WOUND COMPLICATION. IN THIS SERIES, OF OBESE AND MORBIDLY OBSESS PATIENTS, THREE STEMS (6%) REQUIRED REVISION, NONE FOR ASEPTIC LOOSENING. ONE ADDITIONAL FEMORAL PROSTHESIS, (2%) WAS CONSIDERED LOOSE BY RADIOGRAPHIC CRITERIA, AND OSTEOLYSIS WAS IDENTIFIED IN 6%. IN THE CURRENT REVIEW OF 47 PATIENTS (55 HIPS), ONE PATIENT (2%) DEVELOPED A POST OPERATIVE DEEP VEIN THROMBOSIS. NO PATIENTS REQUIRED READMISSION FOR A POST OPERATIVE WOUND INFECTION AND THERE WERE NO POST-OPERATIVE DISLOCATIONS. IN THE ENTIRE COHORT OF 119 HIPS ONLY ONE FEMORAL COMPONENT WAS REVISED FOR ASEPTIC LOOSENING AND ONE WAS LOOSE BY RADIOGRAPHIC CRITERIA. BASED ON THESE FINDINGS, IT IS BELIEVED THAT THE TAPERLOC FEMORAL COMPONENT CAN PROVIDE DURABLE LONG TERM FIXATION IN OBESE PATIENTS UNDERGOING PRIMARY TOTAL HIP ARTHROPLASTY.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "UNCEMENTED TOTAL HIP ARTHROPLASTY USING A TAPERED FEMORAL COMPONENT IN OBESE PATIENTS: AN 18¿27 YEAR FOLLOW-UP STUDY." THERE ARE MULTIPLE EVENTS REPORTED IN THE ARTICLE. THIS REPORT ADDRESSES ONE OF FIVE PATIENTS THAT DIED PRIOR TO ACHIEVING THE MINIMUM 18 YEAR FOLLOW-UP THAT HAD FEMORAL COMPONENTS REVISED. THIS PATIENT THAT UNDERWENT FEMORAL COMPONENT REVISION FOR ASEPTIC LOOSENING AT 10 MONTHS POST-OP SECONDARY TO AN UNRECOGNIZED INTRAOPERATIVE CALCAR FRACTURE ON AN UNKNOWN DATE. THE STEM HAD SUBSIDED 2CM AND WAS FOUND TO BE GROSSLY LOOSE AT THE TIME OF THE REVISION. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623911 UNKNOWN HIP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R