BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HARD BEARING INST RING SZ H

    MDR report key: 10086171 · Received May 26, 2020

    Report

    Report Number
    3002806535-2020-00253
    Event Type
    Malfunction
    Date Received
    May 26, 2020
    Date of Event
    February 6, 2020
    Report Date
    July 6, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    K150522
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    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. THE EVENT REPORTS THAT DURING SURGERY THE DM INSERTER RING CRACKED AND THEN BROKE UPON THE ATTEMPT TO PLACE ON THE LINER. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. THE RETURNED PRODUCT IS NOT COMPLETE. A SECTION OF THE RING IS MISSING AND HAS NOT BEEN RETURNED. THE DEVICE SHOWS EXCESSIVE DAMAGE WITH INDENTATIONS AND SCUFFS VISIBLE AROUND THE FRACTURED AREAS. THE MOST LIKELY ROOT CAUSE OF THE INSERTER RING FRACTURING IS DAMAGE CAUSED BY INCORRECT USE, THIS IS EVIDENT ON THE AREAS OF THE RING WHERE THE BREAKAGE OCCURRED. THE PRODUCT MOST LIKELY LEFT ZIMMER BIOMET CONTROL CONFORMING. NO LOT NUMBER AVAILABLE TO LOCATE MANUFACTURING RECORDS. NO CORRECTIVE OR PREVENTATIVE ACTIONS NEEDED AT THIS TIME. IT HAS BEEN DETERMINED THAT THIS COMPLAINT IS NOT A NEW CONFIRMED QUALITY OR MANUFACTURING ISSUE. COMPLAINTS ARE MONITORED THROUGH MONTHLY COMPLAINT REVIEWS (REFERENCE SOP163) IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. G7 INSTRUMENT REPROCESSING GUIDE 0068.1-US-EN PAGE 8 OF THE REPROCESSING GUIDE DEFINES THE INSPECTIONS REQUIRED AND NOTES THE FOLLOWING: BIOMET DOES NOT DEFINE A MAXIMUM NUMBER OF REPROCESSING CYCLES. THE REUSE LIFE OF THESE DEVICES DEPENDS ON MANY FACTORS INCLUDING THE METHOD AND DURATION OF EACH USE, AND THE HANDLING BETWEEN USES. CAREFUL INSPECTION AND FUNCTIONAL TESTS OF THE DEVICE BEFORE USE IS THE BEST METHOD OF DETERMINING THE END OF SERVICEABLE LIFE FOR A REUSABLE INSTRUMENT. G7 SURGICAL TECHNIQUE 00190.3-EU-EN PAGE 28 DESCRIBES THE USE OF THE HARD BEARING INSERTER RING. A REVIEW OF THE COMPLAINTS DATA BASE HAS FOUND NO SIMILAR REPORTED EVENTS FOR THIS ITEM. USER ERROR: USER USES DAMAGED INSTRUMENTS // DECREASED PERFORMANCE OF G7 HARD BEARING RINGS OR FAILURE CAUSING UTILIZATION OF INAPPROPRIATE INSTRUMENTS OR SURGICAL DELAY. THIS EVENT OCCURRED DURING SURGERY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. THIS GIVES A SEVERITY SCORE OF 2, POTENTIAL FOR EXTENDED SURGERY TIME WHILE A NEW IMPLANT WAS LOCATED. THE SEVERITY OF THE EVENT AS REPORTED IS WITHIN THE ACCEPTABLE LIMITS AS SET OUT IN THE RISK MANAGEMENT FILE. RISK ASSESSMENT: THE ACTUAL SEVERITY SCORE IS IN LINE WITH THE RISK FILE. OCCURRENCE RATE ASSESSMENT: THE CURRENT OCCURRENCE RATING IN THE RISK MANAGEMENT FILE ARE STILL RELEVANT AND HAVE NOT BEEN EXCEEDED; IT IS NOT POSSIBLE TO MAKE A CALCULATION BASED ON ONE INSTANCE OF A COMPLAINT. THE FAILURE MODE WILL BE MONITORED THROUGH ZIMMER BIOMET INTERNAL COMPLAINT AND POST MARKET SURVEILLANCE ACTIVITIES WITH FURTHER REVIEW OF RISK CONDUCTED THROUGH THESE PROCESSES. 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 DURING SURGERY THE DM INSERTER RING CRACKED AND THEN BROKE UPON THE ATTEMPT TO PLACE ON THE LINER. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE BUT NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING 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 DURING SURGERY THE DM INSERTER RING CRACKED AND THEN BROKE UPON THE ATTEMPT TO PLACE ON THE LINER. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE BUT NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551114 G7 HARD BEARING INST RING SZ H ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR LPH BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1