BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CER BIOLOXD OPTION HD 40MM

    MDR report key: 10354696 · Received August 3, 2020

    Report

    Report Number
    3002806535-2020-00347
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    July 6, 2020
    Report Date
    November 27, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    K192683
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00346-1. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. WE HAVE NOT BEEN PROVIDED WITH X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND THREE SIMILAR COMPLAINTS FOR THE ITEM 650-1068. THERE WERE (0) ADDITIONAL COMPLAINTS AGAINST THE LOT 2989630. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND ONE SIMILAR COMPLAINTS FOR THE ITEM 650-1058. THERE WERE (0) ADDITIONAL COMPLAINTS AGAINST THE LOT 2993267. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, THE ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY. RISK ASSESSMENT: THE EVENT REPORTS IMPLANT WOULD NOT SEAT PROPERLY. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE, THEREFORE THE SPECIFIC FAILURE CAUSE WITHIN THE RISK TABLES COULD NOT BE SELECTED FOR COMPARISON. THE REPORTED EVENT STATES IMPLANT WOULD NOT SEAT PROPERLY. LINES 1.2.1.2 AND 1.2.1.4 OF RISK FILE I/O TABLE (B)(4) REV 03 RELATE TO THE REPORTED EVENT. THE AVAILABLE DETAILS FOR THE REPORTED EVENT DO NOT ALLEGE THAT THERE WAS ANY PATIENT HARM OR DELAY TO SURGERY. THEREFORE, THE SEVERITY IS CONSIDERED S-1 (NEGLIGIBLE) AS PER DEFINITIONS WITHIN THE SEVERITY TABLE IN RMR ATTACHED. THE OUTCOME OF THE REPORTED EVENT IS CONSIDERED TO BE WITHIN THE SEVERITY OF THE RMF. IF FURTHER INFORMATION REGARDING THE ROOT CAUSE OF THE REPORTED EVENT IS PROVIDED, RISK SHOULD BE RE-ASSESSED. H3 OTHER TEXT : PRODUCT NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEAD AND SLEEVE DID NOT SEEM TO SIT PROPERLY ON STEM. NO DELAY OF THE PROCEDURE REPORTED. NO HAM REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS AVAILABLE TO BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT MEDICAL DEVICES: MEDICAL PRODUCT: CER OPTION TYPE 1 TPR SLEVE +6, CATALOG #: 650-1068, LOT #: 2989630. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00346. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEAD AND SLEEVE DID NOT SEEM TO SIT PROPERLY ON STEM SURGEON REQUESTED A NEW IMPLANT. NO DELAY OF THE PROCEDURE REPORTED. NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819534 CER BIOLOXD OPTION HD 40MM CERAMIC FEMORAL HEAD PROSTHESIS LPH BIOMET UK LTD. N/A 2993267

    Patients

    Seq Age Sex Outcome Treatment
    1