BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION CONSTRAINING RING, GROUP 1

    MDR report key: 15348595 · Received September 2, 2022

    Report

    Report Number
    1038671-2022-01019
    Event Type
    Injury
    Date Received
    September 2, 2022
    Date of Event
    August 9, 2022
    Report Date
    May 12, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWZ
    UDI-DI
    10885862037145
    PMA / PMN Number
    K071676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. PENDING DEVICE RETURN. CONCOMITANT MEDICAL PRODUCTS: NV CROWN CUP CONSTRAINED LINER G1 28MM - 134-28-41, 7092276, BIOLOX OPTION ADAPTOR +3.5MM 12/14 - 170-50-03, 7271026, BIOLOX OPTION FEMORAL HEAD 28MM - 170-28-50, 7233893.

    Additional Manufacturer Narrative · 0

    H3: THE FRACTURED CONSTRAINING RING REPORTED MAY HAVE BEEN THE RESULT OF DAMAGING THE LOCKING TAB DURING AN INITIAL IMPLANTATION ATTEMPT AND/OR DURING THE FIRST TIME THE RING WAS REMOVED WITH AN OSTEOTOME. ATTEMPTING TO SEAT A CONSTRAINING RING WITH A DAMAGED LOCKING TAB MAY HAVE RESULTED IN INCOMPLETE SEATING DURING THE SECOND IMPLANTATION ATTEMPT AND SUBSEQUENTLY LED TO ULTIMATE FRACTURE OF THE LOCKING TAB DURING THE REMOVAL WITH AN OSTEOTOME.

    Description of Event or Problem · 0

    RELATED TO 1038671-2022-01018. AS REPORTED, DURING A REVISION SURGERY ON (B)(6) 2022, THE SURGEON IMPLANTED A CONTAINING LINER INTO THE CUP AND PLACED THE CONSTRAINING RING AROUND THE NECK OF THE FEMORAL STEM. THE SURGEON USED THE RING IMPACTOR TOOL TO IMPACT THE RING ALL AROUND THE CUP EDGE. THE RING BLACK LINE MARKS WERE LINED UP WITH THE GAPS/LINES IN THE LINER PER THE SURGICAL TECHNIQUE. AFTER IMPACTING THE RING DOWN, THE SURGEON PLACED THE LEG THROUGH ROM AND STOPPED TO QUESTION WHY THE HEAD DIDN'T LOOK LIKE IT WAS CONSTRAINING OR DOWN IN THE LINER. THE SURGEON ASKED THE TECH FOR AN OSTEOTOME AND POPPED THE RING OFF THE CUP. HE THEN PUSHED ON THE LEG TO GET THE HEAD OF THE FEMUR TO SEAT DOWN INTO THE CONSTRAINING LINER, THE HEAD MADE A LOUD CLUNK INTO THE LINER/CUP AND IT WAS CONFIRMED THAT THE HEAD IS NOW DOWN INTO THE LINER PROPERLY. THE SURGEON TOOK THE RING IMPLACTOR TOOL, LINED THE RING BACK UP WITH THE CROSS HATCHES AND BEGAN TO IMPACT THE SAME RING DOWN. THE RING WOULD SEAT AT THREE TABS, BUT THE FOURTH TAB WOULD NOT LOCK DOWN. THE SURGEON TRIED MANY DIFFERENT TOOLS AND TECHNIQUES TO GET THE RING TO LOCK INTO THE CUP PROPERLY AND IT WOULD NOT. THE RING WAS NOT GOING TO FUNCTION PROPERLY AND LOCK/CONTRAIN THIS PATIENT. THE SURGEON USED AN OSTEOTOME TO REMOVE THE RING AND WHEN DOING SO A PRONG OR CLIP ON THE CONSTRAINING RING BROKE OFF AND LANDED ON THE SURROUNDING TISSUE. THE BROKEN PIECE WAS REMOVED FROM THE SURGICAL SITE AND ISOLATED ON THE BACK TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539322 NOVATION CONSTRAINING RING, GROUP 1 PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER KWZ EXACTECH, INC. NOVATION CONSTRAINING RING, GROUP 1 10885862037145

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Other SEE H10.