BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM RINGLOC -X +5 52/36MM

    MDR report key: 9334134 · Received November 18, 2019

    Report

    Report Number
    3002806535-2019-00873
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    August 13, 2019
    Report Date
    April 16, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWZ
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CMP-(B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G4, H1, H2, H3, H6, H10. PRODUCT WAS RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE COMPLAINTS PRODUCT EVALUATION ENGINEER FOR INVESTIGATION. THE PRODUCT SHOWS SIGNS OF DAMAGE WHICH IS MOST LIKELY DUE TO THE SURGEONS ATTEMPT TO FIT THE LINER TO THE MALLORY SIZE 52MM CUP. THE DRAWINGS CONFIRM THAT THE FREEDOM RINGLOC-X LINER +5 52/36MM WILL NOT FIT INTO A 52MM MALLORY-HEAD SHELL. THE OUTER RADIUS OF THE LINER IS LARGER THAN THE INNER RADIUS OF THE MALLORY-HEAD SHELL. FURTHER EVIDENCE CAN BE FOUND IN THE FREEDOM CONSTRAINED LINER SURGICAL TECHNIQUE ¿ FLH226 04/11 WHERE IMPLANT TABLE CLEARLY STATES THAT ITEM 11-253652 FALLS BETWEEN RINGLOC SIZE 23 AND 24 INDICATING THAT IT IS NOT COMPATIBLE WITH THESE STANDARD RINGLOC SHELLS. THE FREEDOM CONSTRAINED LINER THAT WAS SUCCESSFULLY IMPLANTED WAS ITEM 11-107022 WHICH IS A SIZE 23 LINER. THE MHR RELATED TO THE INVOLVED PRODUCT HAS BEEN REVIEWED AND DOES NOT SHOW ANY NON-CONFORMITY, REJECTION OR CONCESSION THAT COULD BE RELATED TO THE REPORTED EVENT. ALL THE LOT (6 UNITS) WAS ACCEPTED AT THE TIME OF MANUFACTURING. RESULTS OF IMPLANT COMPATIBILITY REVIEW: FREEDOM RINGLOC-X CONSTRAINED LINER ITEM 11-253652 IS NOT COMPATIBLE WITH STANDARD RINLOC SHELLS. FREEDOM CONSTRAINED LINER SURGICAL TECHNIQUE ¿ FLH226 04/11 STATES THE FOLLOWING: THE FREEDOM-X CONSTRAINED LINERS IN SIZES 50MM, 52MM, 54MM ETC ARE USED WITH THE EXCEED ABT RINGLOC-X RANGE OF ACETABULAR SHELLS. THE FREEDOM-X CONSTRAINED LINERS IN SIZES 23, 24, 25 ETC ARE ALSO COMPATIBLE WITH THE REGENEREX RINGLOC+ AND RINGLOC ACETABULAR SHELLS. FROM THE IMPLANT TABLE WITHIN THE SURGICAL TECHNIQUE ITEM 11-253652 IS NOT COMPATIBLE WITH A 52MM MALLORY-HEAD SHELL. IMPROPER COMPONENT SELECTION. THE FREEDOM RINGLOC-X +5 52/36MM CONSTRAINED LINER (ITEM 11-253652) IS NOT COMPATIBLE WITH THE 52MM MALLORY SHELL. 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 A PATIENT UNDERWENT REVISION SURGERY. SUBSEQUENTLY, THE LINER 11-253650 DIDN'T FIT IN THE MALLORY CUP SIZE 52 AND THEREFORE IT WAS DECIDED TO PLACE A REGULAR OFFSET LINER

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: REPORT SOURCE, FOREIGN: EVENT OCCURRED IN (B)(6). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: MALLOY CUP SIZE 52, CATALOG #: NOT REPORTED, LOT #: NOT REPORTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY. SUBSEQUENTLY, THE LINER 11-253650 DIDN'T FIT IN THE MALLORY CUP SIZE 52 AND THEREFORE IT WAS DECIDED TO PLACE A REGULAR OFFSET LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133957 FREEDOM RINGLOC -X +5 52/36MM HIP PROSTHESIS KWZ BIOMET UK LTD. N/A 3491780

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R