BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK TAPERLOC CEMENTLESS STEM

    MDR report key: 9375853 · Received November 26, 2019

    Report

    Report Number
    3002806535-2019-00900
    Event Type
    Injury
    Date Received
    November 26, 2019
    Report Date
    April 24, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G4, G7, H1, H2, H10. G3: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN THE UNITED KINGDOM. D11: DEVICE NAME: UNKNOWN CONTINUUM, MODEL#: UNKNOWN, LOT#: UNKNOWN. PRODUCT HAS NOT BEEN RECEIVED TO ZIMMER BIOMET FOR INVESTIGATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS COULD NOT BE PERFORMED AS THE ITEM NUMBER AND LOT NUMBER IS UNKNOWN. A REVIEW OF THE COMPLAINT DATABASE COULD NOT BE PERFORMED AS ITEM NUMBER IS UNAVAILABLE. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D10, G4, H1, H2, H3, H6, H10 THE INFORMATION RECEIVED FROM NATIONAL JOINT REGISTRY (NJR) REPORTED THAT TEN PATIENTS WITH TAPERLOC CEMENTLESS STEM/ CONTINUUM IMPLANTS WERE REVISED DUE TO UNKNOWN REASONS. NO FURTHER INFORMATION IS AVAILABLE FROM THE NJR. THE NJR INDICATED THAT INSPECTION OF THE DATA SHOWS THAT THE CALCULATED PTIR (REVISION RATE PER ONE HUNDRED PATIENT YEARS OF IMPLANTATION) OF ALL DEVICES IS TWICE THAT FOR ITS GROUP PTIRS, AND AS SUCH THE NJR REPORTED THEIR FINDINGS TO THE MHRA. THE MHRA REQUESTED ANALYSIS FROM ZIMMER BIOMET ON (B)(6) 2019. AT THE TIME OF THE NOTIFICATION, THERE WERE 710 OF THESE COMBINATIONS AND 10 REVISIONS (1.41 PERCENT RAW REVISION RATE, PTIR = 1.73). ZIMMER BIOMET INTERNAL ANALYSES OF UK NJR TAPLERLOC CEMENTLESS STEM/CONTINUUM CUP DATA: PATIENT DEMOGRAPHICS SHOW A SIMILAR PROPORTION OF ASA GRADES AND PERCENTAGE OF PATIENTS TREATED FOR OSTEOARTHRITIS WHEN TAPERLOC COMPLETE/CONTINUUM IS COMPARED TO SIMILAR HIP COMBINATIONS IN THE UK NJR. FURTHER REVIEW CONSISTED OF ANALYZING OTHER VARIABLES TO DETERMINE IF ANY WERE SIGNIFICANT IN PREDICTING THE HIGHER REVISION RATES. VARIABLES INCLUDED HEAD SIZE, HEAD AND CUP ARTICULATION, INDICATION AND YEAR OF SURGERY. NONE OF THESE VARIABLES SHOWED A CLEAR TREND, HOWEVER, ALL REVISIONS OCCURRED WITHIN 6 MONTHS OF SURGERY, WITH 6 REVISIONS OCCURRING RIGHT AFTER SURGERY DUE TO PERIPROSTHETIC FRACTURE OR DISLOCATION. MOST OF THE SURGERIES FOR THIS COMBINATION WERE WITHIN THE PAST TWO YEARS. THIS CONTRIBUTES TO A HIGHER PTIR AS IT IS WELL KNOWN THAT HIGHER REVISION RATES OCCUR DURING THE FIRST TWO YEARS AFTER SURGERY. THE PTIR IS EXPECTED TO DECREASE AS PATIENTS ACCRUE TIME, ESPECIALLY SINCE ALL REVISIONS THUS FAR OCCURRED WITHIN SIX MONTHS OF SURGERY. NEXT, REVISION RATES BY SITE AND BY SURGEON WERE ANALYZED. ASSESSMENT REVEALED NO APPARENT SURGEON OR SURGICAL SITE CLUSTERING. NO SURGEON OR SURGICAL CENTER EXPERIENCED MORE THAN TWO REVISIONS WITH THE EXCEPTION OF SURGICAL SITE 4327, EXPERIENCING 3 REVISIONS OUT OF 168 IMPLANTED. SURGICAL SITE 4327 HAD THE MOST IMPLANTS OF TAPERLOC/CONTINUUM. TWO OF THE REVISIONS AS THIS SITE WERE FOR DISLOCATION AND ONE WAS FOR PERIPROSTHETIC FRACTURE. LASTLY, WE SEARCHED 18 NATIONAL REGISTRIES AND NO OTHER REGISTRIES REPORTED ON THE PERFORMANCE OF THIS SPECIFIC COMBINATION. IN SUMMARY, TAPLERLOC CEMENTLESS STEM/CONTINUUM CUP COMBINATION SHOWS HIGHER REVISION RATES WHEN COMPARED TO OTHER SIMILAR CEMENTLESS STEMS AND CUPS IN THE UK NJR. PATIENT DEMOGRAPHICS, IMPLANT SIZES, AND IMPLANT ARTICULATION DO NOT APPEAR TO BE RELATED TO THE HIGHER REVISION RATE. THE DATA ALSO DOES NOT SHOW ANY REVISION CLUSTERING BY SURGEON OR HOSPITAL. ALL TEN REVISIONS OCCURRED WITHIN 6 MONTHS OF SURGERY. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY. PRODUCT NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 REVISIONS WERE IDENTIFIED BY NJR FOR THE TAPERLOC CEMENTLESS STEM/ CONTINUUM IN PRIMARY HIP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 REVISIONS WERE IDENTIFIED BY NJR FOR THE TAPERLOC CEMENTLESS STEM/ CONTINUUM IN PRIMARY HIP.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 10 REVISIONS WERE IDENTIFIED BY NJR FOR THE TAPERLOC CEMENTLESS STEM / CONTINUUM FOR AN UNKNOWN REASON IN PRIMARY HIP REPLACEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168928 UNK TAPERLOC CEMENTLESS STEM HIP PROSTHESIS JDI BIOMET UK LTD. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R