BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RLOC-X ARCOMXL H/W 54/36MM 24

    MDR report key: 8403131 · Received March 8, 2019

    Report

    Report Number
    3002806535-2019-00248
    Event Type
    Injury
    Date Received
    March 8, 2019
    Date of Event
    February 12, 2019
    Report Date
    March 20, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2019-00247-1. PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND WERE FORWARDED TO THE COMPLAINTS PRODUCT EVALUATION ENGINEER FOR INVESTIGATION. A 36 MM DIAMETER BIOLOX DELTA CERAMIC FEMORAL HEAD AND A RINGLOC-X ARCOMXL HI-WALL LINER WERE REVISED AFTER APPROXIMATELY 8 WEEKS DUE TO REPORTED LOOSENING. THE RINGLOC-X ARCOM XL HI-WALL LINER DISPLAYS ADVERSE WEAR ON THE NON-ARTICULATING SURFACE AND TWO DEFORMED CASTELLATIONS ON THE RIM. THE LINER HAS UNIDIRECTIONAL GROOVES ON THE SURFACE THAT ARTICULATES WITH THE SHELL.. FURTHERMORE, THE BIOLOX DELTA CERAMIC HEAD SHOWS A LARGE REGION OF METAL TRANSFER. THERE IS A LARGE REGION OF DARK METAL TRANSFER WHICH COVERS APPROXIMATELY 20 PERCENT OF THE BEARING SURFACE. THESE OBSERVATIONS SUGGEST THAT THE LINER HAS DISLOCATED FROM THE SHELL IN VIVO, WHICH MAY HAVE LED TO UNINTENDED ARTICULATION BETWEEN THE CERAMIC HEAD AND THE INNER SURFACE OF THE ACETABULAR SHELL. HOWEVER, THIS CANNOT BE CONFIRMED WITHOUT PRE-REVISION RADIOGRAPHS. ITEMS XL-053654 AND 650-0836 ARE COMPATIBLE WITH EACH OTHER. POST-PRIMARY RADIOGRAPHS HAVE ALSO NOT BEEN PROVIDED WITH (B)(4), THEREFORE, AN ASSESSMENT OF THE INITIAL COMPONENT SIZING, POSITIONING AND ALIGNMENT COULD NOT BE PERFORMED. NO DEVICE OR MANUFACTURING DEFICIENCIES HAVE BEEN IDENTIFIED THAT COULD CAUSE THE REPORTED EVENT. NO RELATIONSHIP OF FUNCTION OR PERFORMANCE OF THE DEVICE HAS BEEN ESTABLISHED TO THE REPORTED EVENT. THE MANUFACTURING HISTORY RECORDS (MHRS) OF THE RETURNED COMPONENTS HAVE BEEN CHECKED AND VERIFY THAT THE PARTS WERE MANUFACTURED AND STERILISED IN ACCORDANCE WITH THE APPLICABLE SPECIFICATIONS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. NO OTHER SIMILAR COMPLAINTS HAVE BEEN REPORTED AGAINST THE ITEM. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    REVISION DUE TO LOOSENING.

    Additional Manufacturer Narrative · 1

    (B)(4). REFER ALSO TO REPORT - 3002806535-2019-00247. REPORT SOURCE: FOREIGN - EVENT OCCURRED IN (B)(6). INVESTIGATION IS ON-GOING. WHEN INVESTIGATION HAS BEEN COMPLETED, FOLLOW UP MDR REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REVISION DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197898 RLOC-X ARCOMXL H/W 54/36MM 24 HIP PROTHESIS JDI BIOMET UK LTD. N/A J3420331

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R