BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF TRL BRG W/SLOTS SML 4MM

    MDR report key: 10634822 · Received October 6, 2020

    Report

    Report Number
    3002806535-2020-00444
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Date of Event
    September 17, 2020
    Report Date
    December 3, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDITIONAL INFORMATION RECEIVED: LOT NUMBER RECEIVED: ZB160301. PRODUCT RETURNED TO ZIMMER BIOMET UK FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE COMPLAINTS PROCESSING UNIT FOR INVESTIGATION. OXFORD POLY TRIAL SIZE SMALL 4 MM PLASTIC PIECE BROKE WHEN REMOVING FROM PATIENT. INSTRUMENT FRACTURE DURING SURGERY. NO HARM HAS BEEN REPORTED TO PATIENT. VISUAL CHECKS OF THE RETURNED PRODUCT OXFORD TRIAL BEARING SZ4 SMALL (ITEM (B)(4), LOT. ZB160301) CONFIRMS THAT THERE IS A FRACTURE ON BOTH SIDES OF THE BOTTOM FACE AND ONE SIDE HAS A PIECE OF THE MATERIAL MISSING. THIS INSTRUMENT IS SHOWING A LOT OF WEAR AND TEAR CONSISTENT WITH MANY YEARS OF USE AS THE INSTRUMENT WAS MANUFACTURED IN 2016. A REVIEW OF THE COMPLAINTS DATABASE SHOWS THAT WE HAVE RECEIVED NO REPORTED EVENTS FOR INSTRUMENT FRACTURE PROBLEM FOR THE SAME ITEM NUMBER (B)(4) PRIOR TO THE REPORTED EVENT. RISK ASSESSMENT: THE SEVERITY OF THE REPORTED EVENT AND CALCULATED OCCURRENCE FOR SIMILAR COMPLAINTS ARE IN LINE WITH THE RISK FILE THE OVERALL SCORE IS LOW RISK. NO CORRECTIVE OR PREVENTIVE ACTION IS CONSIDERED NECESSARY AT THIS TIME. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OXFORD POLY TRIAL SIZE SMALL 4 MM PLASTIC PIECE BROKE WHEN REMOVING FROM PATIENT. NO HARM REPORTED. NO DELAY REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OXFORD POLY TRIAL SIZE SMALL 4 MM PLASTIC PIECE BROKE WHEN REMOVING FROM PATIENT. NO HARM REPORTED. NO DELAY REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. CUSTOMER HAS INDICATED THAT THE PRODUCT IS AVAILABLE 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 THE OXFORD POLY TRIAL SIZE SMALL 4 MM PLASTIC PIECE BROKE WHEN REMOVING FROM PATIENT. NO HARM REPORTED. NO DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097600 OXF TRL BRG W/SLOTS SML 4MM KNEE TIBIA TRIAL PROSTHESIS NRA BIOMET UK LTD. N/A ZB160301

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR