BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HARD BEARING INST RING SZ E

    MDR report key: 12405790 · Received September 1, 2021

    Report

    Report Number
    3002806535-2021-00369
    Event Type
    Malfunction
    Date Received
    September 1, 2021
    Date of Event
    August 16, 2021
    Report Date
    October 19, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWY
    UDI-DI
    05019279999408
    PMA / PMN Number
    K150522
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SUMMARY: PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE COMPLAINTS PROCESSING UNIT FOR INVESTIGATION. THE COMPLAINT STATES: IT WAS REPORTED THAT THE BEARING INSERTER RING BECAME LODGED BETWEEN LINER AND CUP RESULTING IN DEFORMATION OF THE RING. ANOTHER INSTRUMENT WAS READILY AVAILABLE AND OPENED TO SOLVE THE PROBLEM RESULTING IN A MINIMAL DELAY. EVENT OCCURRED DURING SURGERY. NO HEALTH CONSEQUENCES OR IMPACT. THE EVALUATION OF THE RETURNED PRODUCT CONFIRMS THAT THE RING WAS DEFORMED. VISUAL INSPECTION OF THE REPORTED EVENT SHOWED INDENTATIONS ON THE TOP FACE AND THE SIDE OF THE RING. THE RING WAS DAMAGED AND DEFORMED ON THE DIAMETER AND ON THE TOP FACE. IN ADDITION, THE INSTRUMENT SHOWS SIGNS OF WEAR & TEAR WHICH CAN BE EXPECTED WITH REPEATED USE, REPROCESSING AND TIME IN FIELD (APPROXIMATELY 5 YEARS). DIMENSIONAL CHECK WAS NOT CARRIED OUT AS THE INSTRUMENT WAS DAMAGED ON RETURN. CHECK NOT REQUIRED AS COMPONENT WAS NOT A PART OF AN ASSEMBLY. REVIEW OF DECLARATION OF COMPLIANCE FOR RADEL R-5500 PURPLE VT2582 FROM MAITLAND ENGINEERING INC CONFIRMS THAT THE MATERIAL USED TO PRODUCE THE INSTRUMENT WAS CONFORMING TO STANDARDS AND SPECIFICATION PRIOR TO SHIPMENT TO ZB. A REVIEW OF THE CERTIFICATE OF CONFORMANCE FROM MAITLAND ENGINEERING INC CONFIRMS THAT THE RING WAS PROCESSED AND VERIFIED IN LINE WITH THE SPECIFICATION AND QUALITY CHARACTERISTICS AS DEFINED BY ZIMMER BIOMET. THE PRODUCT ITEM NO. 110026854 HAS NOT BEEN INVOLVED IN ANY PREVIOUS FIELD ACTIONS. THE ROOT CAUSE CANNOT BE CONFIRMED WITH THE AVAILABLE INFORMATION HOWEVER, THE LIKELY ROOT CAUSE OF THE REPORTED EVENT IS MISUSE BY THE USER. THE RESULTING FORCES THAT WERE APPLIED TO THE RING, WHICH WAS INCORRECTLY SEATED, CAUSED THE LODGING OF THE RING BETWEEN THE LINER AND THE SHELL AND THE SUBSEQUENT DEFORMATION AND INDENTATIONS. THE HAZARD AND REPORTED HARM ARE COVERED BY THE RISK FILE AND THE SEVERITY/OCCURRENCE AND THE RISK SCORES ARE WITHIN ACCEPTABLE LIMITS. THE OVERALL RISK IS CONSIDERED TO BE NEGLIGIBLE. CAPA: NO CORRECTIVE OR PREVENTIVE ACTION REQUIRED AT THIS TIME. INVESTIGATION IS COMPLETED BASED ON CURRENT AVAILABLE INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BEARING INSERTER RING BECAME LODGED BETWEEN LINER AND CUP RESULTING IN DEFORMATION OF THE RING. ANOTHER INSTRUMENT WAS READILY AVAILABLE AND OPENED TO SOLVE THE PROBLEM RESULTING IN A MINIMAL DELAY.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. 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 BEARING INSERTER RING BECAME LODGED BETWEEN LINER AND CUP RESULTING IN DEFORMATION OF THE RING. ANOTHER INSTRUMENT WAS READILY AVAILABLE AND OPENED TO SOLVE THE PROBLEM RESULTING IN A MINIMAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306343 G7 HARD BEARING INST RING SZ E G7 INSTRUMENTS KWY BIOMET UK LTD. N/A 579670 05019279999408

    Patients

    Seq Age Sex Outcome Treatment
    1 Other