BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF TRIAL BEARING MED SZ 4/5

    MDR report key: 11472786 · Received March 12, 2021

    Report

    Report Number
    3002806535-2021-00078
    Event Type
    Malfunction
    Date Received
    March 12, 2021
    Date of Event
    February 25, 2021
    Report Date
    April 28, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HRY
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE COMPLAINTS PRODUCT EVALUATION ENGINEER FOR INVESTIGATION. VISUAL INSPECTION CONFIRMED THAT THE HANDLE HAD SEPARATED FROM THE 5MM TRIAL BEARING. THERE IS ALSO EVIDENCE OF HEAVY WEAR AND DAMAGE TO THE BEARING. REVIEW OF THE CERTIFICATES OF CONFORMANCE FROM BOTH THE MANUFACTURER (SYMMETRY MEDICAL [OTHY]) AND THE RAW MATERIAL SUPPLIER (WESTLAKE PLASTICS COMPANY) CONFIRMS THAT THE MATERIAL COMPLIES TO REQUIRED REQUIREMENTS OF THE SPECIFICATION. A REVIEW OF COMPLAINT HISTORY WAS ASSESSED FOR THREE YEARS PRIOR TO THE NOTIFICATION DATE AND IDENTIFIED (3) TOTAL COMPLAINTS ABOUT ITEM 32-4203784. THERE WERE (0) ADDITIONAL COMPLAINTS AGAINST THE LOT 299603. THE MOST LIKELY ROOT CAUSE IS EXPECTED WEAR AND TEAR DUE TO THE TIME SPENT IN THE FIELD (APPROXIMATELY 16 YEARS). THE HAZARD AND REPORTED HARM ARE COVERED BY THE RISK FILE AND THE SEVERITY/OCCURRENCE AND THE RISK SCORES ARE WITHIN ACCEPTABLE LIMITS. THE RISK IS CONSIDERED TO BE NEGLIGIBLE.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H10 ADDITIONAL INFORMATION RECEIVED: PRODUCT LOT NUMBER RECEIVED: 299603 THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER CEMENTING THE TIBIAL AND THE FEMORAL COMPONENT A 4MM GAUGE WAS INSERTED UNTIL THE CEMENT HARDENED. A 4MM TRIAL BEARING WAS USED TO CHECK THE STABILITY BEFORE PROCEEDING THE REAL IMPLANT, THEN TRIALLED THE 5MM. SUBSEQUENTLY, THE INSTRUMENT BROKE OFF (WHERE THE THREADED PORTION SCREWS INTO THE PLASTIC TRIAL). THE BLUE TRIAL WAS REMOVED WITH A TOWEL CLIP. ONCE REMOVED THE WOUND WAS IRRIGATED AND INSERTED THE REAL IMPLANT. NO DELAY OF THE PROCEDURE REPORTED. NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER CEMENTING THE TIBIAL AND THE FEMORAL COMPONENT A 4MM GAUGE WAS INSERTED UNTIL THE CEMENT HARDENED. A 4MM TRIAL BEARING WAS USED TO CHECK THE STABILITY BEFORE PROCEEDING THE REAL IMPLANT, THEN TRIALLED THE 5MM. SUBSEQUENTLY, THE INSTRUMENT BROKE OFF (WHERE THE THREADED PORTION SCREWS INTO THE PLASTIC TRIAL). THE BLUE TRIAL WAS REMOVED WITH A TOWEL CLIP. ONCE REMOVED THE WOUND WAS IRRIGATED AND INSERTED THE REAL IMPLANT. THIS TRAY WAS NOT CONSIGNED TO THE HOSPITAL IT WAS A LOANER TRAY. NO DELAY OF THE PROCEDURE REPORTED. NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. PRODUCT HAS BEEN REQUESTED TO BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 AFTER CEMENTING THE TIBIAL AND THE FEMORAL COMPONENT A 4MM GAUGE WAS INSERTED UNTIL THE CEMENT HARDENED. A 4MM TRIAL BEARING WAS USED TO CHECK THE STABILITY BEFORE PROCEEDING THE REAL IMPLANT, THEN TRIALLED THE 5MM. SUBSEQUENTLY, THE INSTRUMENT BROKE OFF (WHERE THE THREADED PORTION SCREWS INTO THE PLASTIC TRIAL). THE BLUE TRIAL WAS REMOVED WITH A TOWEL CLIP. ONCE REMOVED THE WOUND WAS IRRIGATED AND INSERTED THE REAL IMPLANT. THIS TRAY WAS NOT CONSIGNED TO THE HOSPITAL IT WAS A LOANER TRAY. NO DELAY OF THE PROCEDURE REPORTED. NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375367 OXF TRIAL BEARING MED SZ 4/5 KNEE ARTHROPLASTY HRY BIOMET UK LTD. N/A 299603

    Patients

    Seq Age Sex Outcome Treatment
    1