BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLS SPOTORNO, STEM, 135 UNCEMENTED, 15.0, TAPER 12/14

    MDR report key: 7822498 · Received August 28, 2018

    Report

    Report Number
    0009613350-2018-00815
    Event Type
    Injury
    Date Received
    August 28, 2018
    Date of Event
    January 8, 2017
    Report Date
    December 4, 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

    DHR REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. 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) 2017 DUE TO PERIPROSTHETIC FRACTURE. ALL COMPONENTS: DUROM RESURFACING CUP (REF:01.00214.054, LOT:2361096) , METASUL LDH (REF:01.00181.480, LOT:2367396) AND CLS VARUS STEM (REF:290039150, LOT:2223045) WERE EXPLANTED. 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 FIELD ARE MARKED AS "NO". DEVICES ANALYSIS NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ACCORDING T THE AVAILABLE INFORMATION, THE PRODUCT LOCATION IS UNKNOWN. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED 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. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. IN GENERAL, BONE FRACTURE COULD BE DUE TO DEVICE-RELATED FACTORS LIKE MALPOSITIONING, WRONG SIZE COMPONENT AND STEM LOOSENING, AS WELL AS PATIENT FACTORS LIKE BAD BONE QUALITY, INAPPROPRIATE ACTIVITY AND TRAUMA INCIDENT. 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 BY NJR THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE.

    Additional Manufacturer Narrative · 1

    UDI#: (B)(4). CONCOMITANT MEDICAL PRODUCTS: METASUL LDH, HEAD, 48, CODE N, TAPER 18/20, CATALOG NO# 0100181480, LOT NO# 2367396. METASUL DUROM, COMPONENT FOR ACETABULUM, 54/48, CODE N, CATALOG NO# 0100214054, LOT NO# 2361096. CONCOMITANT MEDICAL PRODUCTS: THERAPY DATE : (B)(6) 2017. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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 STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662415 CLS SPOTORNO, STEM, 135 UNCEMENTED, 15.0, TAPER 12/14 CLS SPOTORNO STEM LZO ZIMMER GMBH N/A 2223045

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R