BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLS SPOTORNO, STEM, 125, UNCEMENTED, 9.0, TAPER 12/14

    MDR report key: 7821777 · Received August 28, 2018

    Report

    Report Number
    0009613350-2018-00837
    Event Type
    Injury
    Date Received
    August 28, 2018
    Date of Event
    December 30, 2014
    Report Date
    November 30, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PK042249
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D11 - MEDICAL DEVICES: METASUL DUROM, COMPONENT FOR ACETABULUM, 48/42, CODE H, CATALOG NO# 01.00214.048 ; LOT NO# UNKNOWN, METASUL LDH, HEAD, 42, CODE H, TAPER 18/20, CATALOG NO# 01.00181.420 ; LOT NO# UNKNOWN. DEVICE HISTORY RECORDS (DHR): 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. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: PERIPROSTHETIC FRACTURE. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT RECEIVED A LEFT HIP IMPLANT ON (B)(6) 2007 AND WAS REVISED ON (B)(6) 2014 DUE TO PERIPROSTHETIC FRACTURE NEAR THE STEM. ALL COMPONENTS: DUROM RESURFACING CUP SIZE 48/H (REF:(B)(4). LOT:236), METASUL LARGE BALL HEAD 42MM (REF:(B)(4). LOT:227 ), CLS SPOTORNO STEM (REF:(B)(4). LOT:232) WERE EXPLANTED. THE LOT NUMBER 236, 232, 227 ARE NOT AVAILABLE IN ZIMMERBIOMET DATABASE, THEREFORE CONSIDERED AS UNKNOWN. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES, CASE-RELEVANT DOCUMENTS OTHER THAN UK NJR DATABASE ENTRY WERE RECEIVED. IN NJR DATABASE, THE "MALALIGNMENT", "WRONG SIZING" , "ASEPTIC LOOSENING", "LYSIS" AND "WEAR OF ACETABULAR COMPONENT" IN THE REASON OF REVISION ARE MARKED AS "NO". DEVICES ANALYSIS NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ACCORDING O THE AVAILABLE INFORMATION, THE PRODUCT LOCATION IS UNKNOWN. REVIEW OF PRODUCT DOCUMENTATION - THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. IN GENERAL, BONE FRACTURE COULD BE DUE TO DEVICE-RELATED FACTORS LIKE MALALIGNMENT, WRONG SIZE COMPONENT AND STEM LOOSENING, AS WELL AS PATIENT FACTORS SUCH AS BAD BONE QUALITY, PERFORMED INAPPROPRIATE ACTIVITY AND UNDERWENT TRAUMA. ALTHOUGH NJR DATABASE PROVIDE INFORMATION REGARDING THE REVISION REASON, THOSE POSSIBLE ROOT CAUSE COULD NOT BE EXCLUDED AS NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANTS WERE RECEIVED TO CONFIRM THOSE DATA. MOREOVER, PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), RELEVANT MEDICAL HISTORY AND WHETHER THE PATIENT UNDERWENT TRAUMA ARE UNKNOWN. THEREFORE, BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. 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 · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: METASUL DUROM, COMPONENT FOR ACETABULUM, 48/42, CODE H, CATALOG NO# 0100214048 ; LOT NO# UNKNOWN, CLS SPOTORNO, STEM, 125, UNCEMENTED, 9.0, TAPER 12/14, CATALOG NO# 0100295009 ; LOT NO# UNKNOWN. THERAPY DATE : (B)(6) 2014. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON THE LEFT SIDE AND UNDERWENT REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE OF STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663073 CLS SPOTORNO, STEM, 125, UNCEMENTED, 9.0, TAPER 12/14 CLS SPOTORNO STEM LZO ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R