BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 50/44, CODE J

    MDR report key: 7828145 · Received August 29, 2018

    Report

    Report Number
    0009613350-2018-00892
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    December 4, 2015
    Report Date
    January 16, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    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 QUALITY RECORDS INDICATE THAT THESE COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: OSTEOLYSIS AND ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS. EVENT SUMMARY: IT WAS REPORTED THAT THE PATIENT RECEIVED A LEFT HIP IMPLANT ON (B)(6), 2005 AND WAS REVISED ON (B)(6), 2015 DUE TO OSTEOLYSIS AROUND THE CUP AND THE STEM AND ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS. REVIEW OF RECEIVED DATA NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. REVIEW OF PRODUCT DOCUMENTATION THE COMPATIBILITY CHECK OF DUROM CUP AND METASUL LDH WAS PERFORMED FROM (B)(6) AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. HOWEVER, DUE TO THE UNKNOWN INFORMATION OF HEAD ADAPTER, THE COMPATIBILITY BETWEEN HEAD AND STEM COULD NOT BE CHECKED. DEVICES ANALYSIS NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. CONCLUSION SUMMARY THE IMPLANT WAS REVISED DUE TO ADVERSE TISSUE REACTION TO PARTICLE DEBRIS AND OSTEOLYSIS AROUND THE CUP AND STEM. THE IN VIVO TIME WAS 10.2 YEARS. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THE ISSUE RELATED TO DURUM CUP IS A KNOWN ISSUE AND HAVE BEEN ADDRESSED IN CP00000620 (ERROR PATTERN: POTENTIAL EARLY REVISION OF THE ACETABULAR COMPONENT DUE TO LOOSENING, IMPLANT MIGRATION OR UNRESOLVED PAIN, HIGHER ION RELEASE, OSTEOLYSIS AND ARMD). THEREFORE, NO FURTHER INVESTIGATION FOR DUROM CUP COMPONENT WAS REQUIRED. HOWEVER, INVESTIGATION WAS REQUIRED FOR THE STEM AS IT IS NOT COVERED BY CP00000620. POSSIBLE CAUSE FOR OSTEOLYSIS AROUND THE STEM INCLUDES PATIENT FACTORS LIKE AGING AND BIOLOGICAL RESPONSE TO METAL DEBRIS AS WELL AS DEVICE-RELATED FACTORS LIKE WEAR AND STRESS SHIELDING. MICROMOTION/FRETTING AT THE TAPER AND IMPINGEMENT COULD BE ONE OF THE CONTRIBUTE FACTOR TO ARMD. HOWEVER, NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANT WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. THEREFORE, DUE TO SIGNIFICANT LACK OF INFORMATION, WE WERE NOT ABLE TO PERFORM A ACCURATE ANALYSIS AND IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. SINCE THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION THERE WILL BE NO FURTHER INVESTIGATION. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4)..

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: METASUL LDH, HEAD, 44, CODE J, TAPER 18/20, CATALOG NO#0100181440, LOT NO# 2266453; CLS® SPOTORNO®, STEM, 135°, UNCEMENTED, 6.0, TAPER 12/14, CATALOG#290039060, LOT#2230167. THERAPY DATE : (B)(6) 2015. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, 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 DUE TO ARMD, LYSIS STEM & SOCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667063 DUROM ACETABULAR COMPONENT 50/44, CODE J DUROM ACETABULAR COMPONENT AND METASUL LDH KWA ZIMMER GMBH N/A 2263688

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R