BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLOFIT ALLOCLASSIC, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 56/KK

    MDR report key: 6809888 · Received August 22, 2017

    Report

    Report Number
    0009613350-2017-01089
    Event Type
    Malfunction
    Date Received
    August 22, 2017
    Date of Event
    July 20, 2017
    Report Date
    August 22, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2017. TREND ANALYSIS: DURING THE TREND ANALYSIS, NO TREND WAS IDENTIFIED. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT SUMMARY: AN ALLOFITCUP SIZE 56/KK (REF: 4247 LOT: 2891035) HAS BEEN RECEIVED. IT HAS BEEN REPORTED THAT THE POLARPLUG THREAD WAS DAMAGED DURING THE ASSEMBLY WITH THE SETTING INSTRUMENT. THE SURGEON STATES THAT WHILE TRYING TO ASSEMBLE THE CUP WITH THE INSTRUMENT HE DAMAGED THE CUP'S THREAD. AFTER THAT THE SURGEON USED ANOTHER CUP WITH THE SAME SIZE WHICH COULD BE ASSEMBLED. REVIEW OF RECEIVED DATA NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS VISUAL EXAMINATION: THE ALLOFITCUP 56/KK RETURNED SHOWED A RIPPED OUT/ DAMAGED THREAD AND SOME SCRATCHES INSIDE THE CUP CAN BE SEEN ON THE OUTER SURFACE NO CONSIDERABLE DAMAGE CAN BE DETECTED. MEASUREMENTS: AS THE POLAR SCREW THREAD OF THE CUP IS DAMAGED NO MEASUREMENTS CAN BE CONDUCTED. THE DHR INDICATES THAT ALL COMPONENTS MET ALL SPECIFICATIONS. FUNCTIONAL TEST: NO FUNCTIONAL TEST WAS PERFORMED BECAUSE THE RETURNED PRODUCT IS DAMAGED. REVIEW OF PRODUCT DOCUMENTATION COMPATIBILITY: NO COMPATIBILITY CHECK CAN BE PERFORMED AS ONLY ONE PRODUCT HAS BEEN REPORTED. ROOT CAUSE ANALYSIS ROOT CAUSE DETERMINATION USING DFMEA - FAILURE OF THE SHELL DUE TO INSUFFICIENT STRENGTH OF SHELL => POSSIBLE: AS THE SCREW THREAD GOT RIPPED OUT/ DAMAGED DURING ASSEMBLY WITH THE SETTING INSTRUMENT. - FAILURE OF THE SHELL DUE TO INSUFFICIENT STRENGTH OF SHELL => POSSIBLE: AS THE SCREW THREAD GOT RIPPED OUT/ DAMAGED DURING ASSEMBLY WITH THE SETTING INSTRUMENT. - DAMAGE OF THE SHELL (CAUSE: IMPACTION DURING IMPLANTATION OR REVISION) DUE TO HIGH LOAD DUE TO IMPACTION DURING THE PRIMARY IMPLANTATION OR REVISION => NOT POSSIBLE: AS ACCORDING TO THE REPORTED EVENT THE SHELL WAS NOT IMPACTED (FAILURE OCCURED WHEN SHELL WAS ASSEMBLED WITH THE SETTING INSTRUMENT) - DIFFICULTIES TO ASSEMBLE COMPONENTS DUE TO HIGH LOAD DUE TO IMPACTION DURING THE PRIMARY IMPLANTATION OR REVISION LEADING TO DAMAGE OF THE SCREW PLUG => NOT POSSIBLE: AS NO DAMAGED SCREW PLUG HAS BEEN REPORTED. - DIFFICULTIES TO ASSEMBLE COMPONENTS DUE TO HIGH LOAD DUE TO IMPACTION DURING THE PRIMARY IMPLANTATION OR REVISION LEADING TO DAMAGE OF THE POLAR PLUG => NOT POSSIBLE: AS NO DAMAGED POLAR PLUG HAS BEEN REPORTED. - DIFFICULTIES TO ASSEMBLE COMPONENTS DUE TO HIGH LOAD DUE TO IMPACTION DURING THE PRIMARY IMPLANTATION OR REVISION LEADING TO DAMAGE OF THE SCREW THREAD OF THE SHELL => POSSIBLE: AS THE THREAD OF THE SHELL IS DAMAGED. HOWEVER, ACCORDING TO THE REPORTED EVENT THIS DID NOT OCCURE DURING IMPACTION OF THE SHELL BUT WHEN ASSEMBLING SHELL AND SETTING INSTRUMENT. POSSIBLY THE SHELL'S THREAD WAS PRE-DAMAGED FROM HANDLING/ TRANSPORT OR THE INSTRUMENT WAS TILTED DURING THE ASSEMBLING WITH THE SHELL. FURTHER FORCES OCCURING DUE TO THE LONG LEVER ARM OF THE INSTRUMENT COULD HAVE DAMAGE THE THREAD. - DIFFICULTIES TO ASSEMBLE COMPONENTS DUE TO SCREW ASSEMBLING FORCE LEADING TO DAMAGE BONE SCREW => NOT POSSIBLE: AS NO DAMAGED BONE SCREW HAS BEEN REPORTED. - IMPLANT IS DAMAGED DUE TO INADEQUATE PACKAGING => NOT POSSIBLE: AS THE REPORTED EVENT IS NOT DIRECTLY RELATED TO INADEQUATE PACKAGING. CONCLUSION SUMMARY BASED ON THE RETURNED PRODUCT AND THE GIVEN INFORMATION THE COMPLAINT COULD BE CONFIRMED. HOWEVER, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. IT REMAINS UNCLEAR WHY THE SHELL'S THREAD GOT DAMAGED DURING ASSEMBLY WITH THE SETTING INSTRUMENT. POSSIBLY THE SHELL'S THREAD WAS PRE-DAMAGED FROM HANDLING/ TRANSPORT OR THE INSTRUMENT WAS TILTED DURING THE ASSEMBLING WITH THE SHELL. FURTHER FORCES OCCURING DUE TO THE LONG LEVER ARM OF THE INSTRUMENT COULD HAVE DAMAGE THE THREAD. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. ZIMMER (B)(4) CONSIDER THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION IS PENDING. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY THE CUP SETTING DEVICE COULD NOT BE SCREWED ONTO THE ALLOFIT CUP. A FURTHER CUP COULD BE EASILY MOUNTED ON THE SETTING DEVICE. NOTES: THE IMPLANTATION AND EXPLANTATION DATES ARE LEFT EMPTY AS THE DEVICE INVOLVED IN THIS COMPLAINT IS AN INSTRUMENT. HENCE, NO EXPIRATION DATE IS CAPTURED, FOR THE SAME REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592011 ALLOFIT ALLOCLASSIC, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 56/KK ALLOFIT ACETABULAR SYSTEM LZO ZIMMER GMBH N/A 2891035

    Patients

    Seq Age Sex Outcome Treatment
    1