BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RLOC-X ARCOMXL H/W 50/32MM 23

    MDR report key: 10263316 · Received July 13, 2020

    Report

    Report Number
    3002806535-2020-00319
    Event Type
    Malfunction
    Date Received
    July 13, 2020
    Date of Event
    June 17, 2020
    Report Date
    September 25, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. G3: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN CHINA. PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE COMPLAINTS PROCESSING UNIT FOR INVESTIGATION. WHEN THE DOCTOR PUT THE RINGLOC-X ARCOMXL H/W 50/32MM 23 INTO THE ACETABULAR CUP, FOUND THAT THE LINER COULD NOT BE FASTENED TIGHTLY AND AFTER SEVERAL EXAMINATIONS AND KNOCKS, THE LINER STILL BECAME LOOSE. THIS HAPPENED DURING SURGERY. VISUAL CHECKS WERE CARRIED OUT ON THE RETURNED LINER, THERE WAS SIGNS OF SEVERE DAMAGE, PARTICULARLY AROUND THE SCALLOPS. IT CANNOT BE DETERMINED IF THIS DAMAGE WAS CAUSED BY REPEATED ATTEMPTS TO IMPACT THE LINER OR FROM ITS REMOVAL. ATTEMPTING TO IMPACT THE LINER, WHERE THE SCALLOPS ARE OUT OF ALIGNMENT, WOULD CAUSE IRREVERSIBLE DAMAGE TO THE LINER SCALLOPS RENDERING IT UNSUITABLE TO BE IMPLANTED SUCCESSFULLY. A REVIEW OF THE COMPLAINTS DATABASE SHOWS THAT WE HAVE RECEIVED 2 REPORTED EVENTS FOR ASSEMBLY ISSUES FOR THE SAME ITEM NUMBER XL-053250 PRIOR TO THE REPORTED EVENT. 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. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. 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 ACTIONS ARE DEEMED NECESSARY AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE OPERATION, WHEN THE DOCTOR PUT THE RINGLOC-X ARCOMXL H/W 50/32MM 23 INTO THE ACETABULAR CUP, HE FOUND THAT THE LINER COULD NOT BE FASTENED TIGHTLY AND BECAME LOOSE. AFTER SEVERAL EXAMINATIONS AND KNOCKS, THE LINER STILL BECAME LOOSE. DELAY OF SURGERY: 20 MINUTES.

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. (B)(6). 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 THE OPERATION, WHEN THE DOCTOR PUT THE RINGLOC-X ARCOMXL H/W 50/32MM 23 INTO THE ACETABULAR CUP, HE FOUND THAT THE LINER COULD NOT BE FASTENED TIGHTLY AND BECAME LOOSE. AFTER SEVERAL EXAMINATIONS AND KNOCKS, THE LINER STILL BECAME LOOSE. DELAY OF SURGERY: 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726423 RLOC-X ARCOMXL H/W 50/32MM 23 NON-CONSTRAINED POLYETHYLENE ACETABULAR LINER LPH BIOMET UK LTD. N/A 6374878

    Patients

    Seq Age Sex Outcome Treatment
    1