BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN WEBER STEM

    MDR report key: 9819396 · Received March 11, 2020

    Report

    Report Number
    0009613350-2020-00113
    Event Type
    Injury
    Date Received
    March 11, 2020
    Report Date
    March 11, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: FOREIGN COUNTRY: (B)(6). CONCOMITANT DEVICE: ALLOCLASSIC CUP, ITEM #: UNKNOWN, LOT #: UNKNOWN. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW, INCLUDING PART AND LOT SPECIFIC INVESTIGATION, COULD NOT BE PERFORMED AS THE ITEM NUMBERS ARE UNKNOWN. DHR REVIEW: AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE MISSING DEVICE INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE. AT ZIMMER GMBH ALL MEDICAL DEVICES PRIOR RELEASE TO MARKET UNDERGO SEVERAL QUALITY INSPECTIONS AS DEFINED IN OUR QUALITY PROCEDURES. OUR QUALITY INSPECTION AND DEVIATION PROCEDURES ENSURE THAT ONLY PRODUCTS FULFILLING THE SPECIFICATION ARE SOLD. THESE PROCEDURES ARE PART OF THE OVERALL QUALITY MANAGEMENT SYSTEM AT ZIMMER GMBH AND GET REGULARLY AUDITED BY OUR NOTIFIED BODY, COMPETENT AUTHORITIES AND INTERNAL AND EXTERNAL AUDITORS. THUS, FOR ALL PRODUCTS SOLD TO THE MARKET CAN BE ASSUMED HAVING A COMPLETE AND CORRECT DHR. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED BY THE (B)(6) THAT THERE WAS A HIGHER THAN EXPECTED REVISION RATE FOR A HYBRID FIXATION OF WEBER STEM AND ALLOCLASSIC CUP. THE REASON FOR EACH OF THE 7 REVISION SURGERIES IS UNKNOWN, BUT COULD HOWEVER BE ONE OF THE FOLLOWING: LOOSENING OF THE ACETABULAR COMPONENT, LOOSENING OF THE FEMORAL COMPONENT, PAIN AND IMPINGEMENT. REVIEW OF RECEIVED DATA: AN OUTLIER REPORT WAS RECEIVED BY THE (B)(6) FOR A HYBRID FIXATION OF WEBER STEM AND ALLOCLASSIC CUP, WHICH REPORTS A HIGHER THAN EXPECTED REVISION RATE. AN OVERVIEW OF PRIMARY IMPLANTS AND REVISION FOR THE TIME-FRAME BETWEEN 2012 AND 2018 WAS RECEIVED. THERE WERE A TOTAL OF 75 PRIMARY IMPLANTS SURGERY WITH WEBER STEM AND ALLOCLASSIC CUP BETWEEN 2012 AND 2018 AND A TOTAL OF SEVEN REVISIONS TOOK PLACE. YEAR WISE IMPLANTS AND REVISION AS FOLLOWS, 2012: IMPLANTED 3 AND REVISED 0, 2013: IMPLANTED 9 AND REVISED 1, 2014: IMPLANTED 15 AND REVISED 1, 2015: IMPLANTED 17 AND REVISED 2, 2016: IMPLANTED 24 AND REVISED 3, 2017: IMPLANTED 6 AND REVISED 0, 2018: IMPLANTED 1 AND REVISED 0. A GENERAL OVERVIEW OF THE REVISED COMPONENTS WERE RECEIVED: 2 REVISION SURGERY HAD THE ACETABULAR AND FEMORAL COMPONENT REVISED. 1 REVISION SURGERY HAD JUST THE ACETABULAR COMPONENT REVISED. 4 REVISION SURGERIES HAD THE FEMORAL COMPONENT REVISED. A GENERAL OVERVIEW OF THE REASON FOR REVISION SURGERIES WAS RECEIVED, WHEREBY THE FOLLOWING WAS NOTED: 1 X DUE TO LOOSENING OF THE ACETABULAR COMPONENT, 6X DUE TO LOOSENING OF THE FEMORAL COMPONENT, 2X DUE TO PAIN AND 1X DUE TO IMPINGEMENT. AN OVERVIEW OF THE AFFECTED HOSPITALS WAS RECEIVED, WHEREBY IN ONLY ONE HOSPITAL ((B)(6)) THERE WERE 7 CASES OF REVISION AFTER 73 IMPLANTATIONS. IN ANOTHER HOSPITAL (UNKNOWN) THERE WERE 2 IMPLANTATIONS AND 0 REVISION SURGERIES. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. IT WAS REPORTED BY THE (B)(6) THAT THERE WAS A HIGHER THAN EXPECTED REVISION RATE FOR A HYBRID FIXATION OF WEBER STEM AND ALLOCLASSIC CUP. THE REASON FOR EACH OF THE 7 REVISION SURGERIES IS UNKNOWN, BUT COULD HOWEVER BE ONE OF THE FOLLOWING: LOOSENING OF THE ACETABULAR COMPONENT, LOOSENING OF THE FEMORAL COMPONENT, PAIN AND IMPINGEMENT. NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANT(S) WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. THE QUALITY RECORDS OF THE PRODUCT COULD NOT BE REVIEWED AS THE REF AND LOT NUMBERS ARE UNKNOWN. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. THEREFORE, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    AS PER OUTLIER REPORT, THERE WAS TOTAL OF 75 PRIMARY IMPLANTS SURGERY WITH WEBER STEM AND ALLOCLASSIC CUP BETWEEN 2012 AND 2018. YEAR WISE IMPLANTS AND REVISION AS FOLLOWS, 2012: IMPLANTED 3 AND REVISED 0, 2013: IMPLANTED 09 AND REVISED 01, 2014: IMPLANTED 15 AND REVISED 01, 2015: IMPLANTED 17 AND REVISED 02, 2016: IMPLANTED 24 AND REVISED 03, 2017: IMPLANTED 06 AND REVISED 00, 2018: IMPLANTED 01 AND REVISED 00. A TOTAL OF SEVEN REVISIONS TOOK PLACE. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED AN ALLOCLASIC CUP ON THE UNKNOWN SIDE AND THE PATIENT UNDERWENT REVISION DUE TO FEMORAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280775 UNKNOWN WEBER STEM UNKNOWN WEBER STEM JDI ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R