BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC-X E1 STD 58/36MM

    MDR report key: 2973170 · Received February 21, 2013

    Report

    Report Number
    3002806535-2013-00027
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 23, 2013
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PK070399
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. DEVICE EVALUATION IN PROCESS. UPON COMPLETION OF EVALUATION, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE RETURNED ACETABULAR LINER WAS EVALUATED AND FOUND THE LINER DIMENSIONS GENERALLY FELL OUTSIDE THE DRAWING TOLERANCE. THIS WAS PROBABLY DUE TO THE COMPONENT HAVING BEEN BADLY DISTORTED IN VIVO, OR HAVING BEEN SUBJECTED TO AN AUTOCLAVE STERILISATION EX VIVO. THE LACK OF WEAR EVIDENCE IN THE BORE, THE BRUISING AROUND THE BORE CHAMFER, AND THE LACK OF DAMAGE TO THE SCALLOPS WOULD INDICATE THAT THE LINER WAS INCORRECTLY FITTED, IN THAT IT DID NOT ENGAGE OR LOCK INTO THE LUGS OF THE ACETABULAR SHELL DURING THE PRIMARY PROCEDURE CAUSING IT TO ROTATE DISTALLY. THE BRUISING AROUND THE BORE CHAMFER WAS PROBABLY CAUSED BY THE FEMORAL STEM NECK COMING INTO CONTACT AND LEVERING THE LINER AGAINST THE ACETABULAR SHELL BORE AND FRACTURING THE SCALLOP DIAMETER RIM THEREBY ALLOWING THE LINER TO ROTATE FULLY AND PERMITTING THE LUXATION. THIS WOULD ALSO EXPLAIN THE HEAVY BRUISING ON THE OUTER SPHERICAL RADIUS, AS THIS AREA OF THE LINER TOOK THE FULL LOADING OF THE JOINT. THE SURGICAL TECHNIQUE STATES "PRIOR TO INSERTING THE LINER, VERIFY THAT THE LOCKING RING IS PROPERLY ALIGNED. LINER TRIALS OR THE APPROPRIATELY SIZED POLYETHYLENE LINER CAN BE USED BEFORE TRIALING THE NECK LENGTH FOR THE FEMORAL COMPONENT. NOTE: AFTER IMPACTING THE POLYETHYLENE, THE RING SHOULD ROTATE FREELY SIDE TO SIDE (WITH PROBE)". THE WEAR DAMAGE TO THE MODULAR HEAD IS INDICATIVE OF THE HEAD COMING INTO CONTACT WITH THE ACETABULAR SHELL, WHICH CAN ONLY HAPPEN IF THE HEAD WEARS THROUGH THE LINER (WHICH HAS NOT BEEN THE CASE IN THIS INSTANCE) OR THE LINER IS NOT CORRECTLY POSITIONED IN SITU.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT SURGERY ON (B)(6), 2012. REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2013 DUE TO LUXATED AND BROKEN INSERT. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77145 RINGLOC-X E1 STD 58/36MM VITAMIN E STD. RINGLOC-X LINER JDI BIOMET UK LTD. N/A 2287820

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R