BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM XL HI-WALL LINER RINGLOC-X SZ 64 (RINGLOC SIZE 27)

    MDR report key: 6250730 · Received January 13, 2017

    Report

    Report Number
    3002806535-2017-00023
    Event Type
    Injury
    Date Received
    January 13, 2017
    Date of Event
    December 15, 2016
    Report Date
    August 7, 2018
    Manufacturer
    .
    Product Code
    LPH
    PMA / PMN Number
    PK042051
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 AND VIGILANCE ENGINEER FOR INVESTIGATION. SUMMARY OF INVESTIGATION: VISUAL CHECKS: THE RETURNED IMPLANTS WERE VISUALLY CHECKED WITH THE FOLLOWING OBSERVATIONS FOUND: RINGLOC-X ARCOM XL H/W 64/36MM MHR-2660051: DAMAGE TO THE TOP FACE NEAR SCALLOPS. BLOOD INGRESS UNDER DAMAGED AREA. VARIOUS INDENTATIONS AND BLOOD MARKING. RINGLOC-X ARCOM XL H/W 64/36MM MHR-3036228: DAMAGE TO THE TOP FACE NEAR SCALLOPS. BLOOD INGRESS UNDER DAMAGED AREA. VARIOUS INDENTATIONS AND BLOOD MARKING. BLOOD INGRESS INSIDE SPHERE WALL. CRACK ALONG THE TOP FACE FROM IMPACT DAMAGE. EXCEED ABT RINGLOC-X SHELL HA/ PC DIA 64MM MHR-2184266: BURRING AND CHIPPING ON TOP SURFACE. BLOOD INGRESS IN INTERNAL SPHERE. BLOOD INGRESS IN BETWEEN APICAL PLUGS AND THREADS. LOCKING RING DAMAGED WITH BLOOD INGRESS. DEEP SCRATCHES AND MARKING IN INTERNAL SPHERE. DIMENSIONAL CHECKS: IT SHOULD BE NOTED THAT THE LINER WAS DAMAGED UPON RECEIPT AND HAS BEEN SUBJECTED TO CLEANING AND DECONTAMINATION PROCESSES BOTH AT THE HOSPITAL AND UPON RETURN TO BIOMET UK LTD AS PER REQUIREMENTS TO ENSURE A DECONTAMINATED PRODUCT BEFORE HANDLING. THEREFORE, ALTHOUGH THE LINER HAS BEEN MEASURED FOR EXTERNAL SPHERICAL RADIUS (FIT AND FUNCTION DIMENSIONS) THE MEASUREMENTS WERE DEEMED TO BE NOT REPRESENTATIVE OF THE FINISHED PRODUCT PRIOR TO THE ATTEMPTED IMPLANTATION AND SUBSEQUENT DAMAGE INCURRED TO THE LINER. DOCUMENT REVIEW: THE BELOW ¿MANUFACTURING HISTORY RECORDS¿ HAVE BEEN REVIEWED WITH THE FOLLOWING OBSERVATIONS: MHR 2184266 EXCEED ABT RINGLOC-X SHELL HA/PC DIA 64MM: 6 DEVICES ON MANUFACTURING RUN. 6 DEVICES PACKAGED. NO DEVIATION, SCRAP OR REWORK RECORDED. MHR 2660051 RINGLOC-X ARCOM XL H/W 64/36MM XL-053664: 8 DEVICES ON MANUFACTURING RUN. 8 DEVICES PACKAGED. NO DEVIATION, SCRAP OR REWORK RECORDED. MHR 3036228 RINGLOC-X ARCOM XL H/W 64/36MM XL-053664: 11 DEVICES ON MANUFACTURING RUN. 11 DEVICES PACKAGED. NO DEVIATION, SCRAP OR REWORK RECORDED. THE CMM DATA WAS NOT AVAILABLE AS ATTACHMENTS TO THE MHR RECORDS FOR THE ABOVE PARTS, HOWEVER, THE REVIEW OF THE APPLICABLE SELF INSPECTION SHEETS AS PART OF THE MHR REVIEW SHOWS THAT ALL OPERATIONS HAD BEEN COMPLETED AND THE REQUIRED MEASUREMENTS AND CHECKS HAD BEEN PERFORMED AND THE OPERATORS AND INSPECTORS HAVE SIGNED OFF EACH ITEM AS ACCEPTABLE. THEREFORE IT IS DEEMED THAT THE PARTS WERE CONFORMING TO PRE-DEFINED SPECIFICATION WHEN MANUFACTURED. COMPLAINTS: A REVIEW OF THE COMPLAINTS DATA BASE SHOWS 13 COMPLAINTS FOR RINGLOC ACETABULAR LINERS NOT SEATING. ASSEMBLY CHECKS: THE RETURNED ITEMS COULD NOT BE ASSEMBLED DUE TO THE DAMAGE SUSTAINED TO THE LINERS AND LOCKING RING COMPONENTS. THE BELOW SURGICAL TECHNIQUE HIGHLIGHTS THE CORRECT PROCEDURE AND CARE REQUIRED WHEN SEATING THE LINER INTO THE SHELL. THE CE CERT FOR THE ITEMS IN QUESTION IS CURRENTLY UNDERGOING ITS RENEWAL PROCESS; THIS INCLUDES AN UPDATE TO THE RISK MANAGEMENT REPORT. FOLLOWING THIS INVESTIGATION, THE INFORMATION HAS BEEN PASSED TO THE DEVELOPMENT ENGINEERING TEAM TO CONSIDER IN THEIR UPDATE TO THE RISK MANAGEMENT REPORT.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4). THIS DEVICE IS 1 OF 2 DEVICES INVOLVED IN THE EVENT AND IT IS UNKNOWN WHICH DEVICE WAS DIFFICULT TO INSERT AND WHICH EXPERIENCED MIGRATION WITHIN THE CUP (REFERENCE 3002806535-2017-00023 & 00024).

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE ACETABULAR LINER WOULD NOT LOCK INTO THE CUP. A SECOND LINER AND LOCKING RING WERE ATTEMPTED, HOWEVER, MOVEMENT OF THE SECOND LINER WITHIN THE CUP WAS NOTED ALONG THE SUPERIOR/POSTERIOR BORDER. THE ACETABULAR CUP WAS REMOVED AND REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER INCIDENT. THIS RESULTED IN A DELAY OF APPROXIMATELY ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34350 ARCOM XL HI-WALL LINER RINGLOC-X SZ 64 (RINGLOC SIZE 27) PROSTHESIS, HIP LPH . N/A 2660051

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R