BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERS 36MM CA ADAPTER ASSEMBLY

    MDR report key: 19061603 · Received April 8, 2024

    Report

    Report Number
    1220246-2024-01870
    Event Type
    Injury
    Date Received
    April 8, 2024
    Date of Event
    March 18, 2024
    Report Date
    September 27, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSD
    UDI-DI
    00888867230378
    PMA / PMN Number
    K151527
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED AR-9502-36ARCA BATCH, 22.02140, WAS RECEIVED FOR EVALUATION. THE DEVICE, ALONG WITH ADDITIONAL COMPONENTS, HAS BEEN RECEIVED FOR INVESTIGATION. A VISUAL INSPECTION HAS SHOWN DAMAGE TO THE THREAD ADAPTER WITH CUTS AND DENTS. DURING FUNCTIONAL TESTING OF THE AR-9555-06, BATCH 22.04623, IT WAS OBSERVED THAT THE DEVICE DID NOT ENGAGE WITH THE MATING COMPONENT. BY DRAWING C13411 AT REVISION 4 SPECIFICATIONS: .409 ± .006. RESULT .411 Ø 1.4547 ± .0012 RESULT. Ø 1.4545 COMPRESSION MOLDED UHMWPE. DRAWING (B)(6) AT REVISION 4. 4331 ± .0059. RESULT .4380 DUE TO DAMAGE TO THE DEVICE, THE ACCURACY OF THE MATERIAL DIAMETER MEASUREMENT WILL BE COMPROMISED. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE SEEMS TO BE A MANUFACTURING ISSUE AS THE DEVICE FIT TOO LOOSE INSIDE THE AR-9555-06, BATCH 22.04623.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9502-36ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 36 CAME LOOSE FROM THE SUTURECUP AND COULD NOT BE SEPARATED. THE TRIAL CA ADAPTER WAS PLACED IN THE SUTURECUP AND THE TRIAL CA HEAD WAS PLACED. AN X-RAY WAS TAKEN, AND IT WAS DETERMINED THAT THE CA HEAD WAS THE APPROPRIATE SIZE. THE TRIALS WERE REMOVED. THE STEM/CUP IMPACTOR HANDLE WAS THREADED INTO THE CA ADAPTER. THE TAB OF THE CA ADAPTER WAS ALIGNED WITH THE LATERAL SLOT OF THE SUTURECUP. THE IMPLANT WAS IMPACTED INTO THE SUTURECUP. THE CA HEAD WAS IMPACTED WITH THE GLENOSPHERE IMPACTOR MAKING SURE THE HOOD OF THE HEAD WAS LATERAL. THE CA ADAPTER CAME LOOSE FROM SUTURECUP. THE SURGEON ASKED FOR A NEW CA ADAPTER AND A CA HEAD AS THEY COULD NOT BE SEPARATED. A SECOND AR-9502-36ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER WAS PLACED ON THE IMPACTOR HANDLE AND WAS IMPACTED INTO THE SUTURECUP. THE GLENOSPHERE IMPACTOR WAS USED AS WELL TO SEAT THE ADAPTER INTO THE SUTURECUP BUT WITH LITTLE EFFORT, THE CA ADAPTER COULD BE PULLED FROM THE SUTURECUP. THE SURGEON WAS ABLE TO SEPARATE THE FIRST SET OF IMPLANTS AND TRIED AGAIN TO IMPACT THE CA ADAPTER INTO THE SUTURECUP, BUT AGAIN IT COULD BE EASILY REMOVED FROM THE SUTURECUP. THE SURGEON MADE SURE THE TAB WAS ALIGNED WITH THE LATERAL SLOT OF THE SUTURECUP. A 36+6 SPACER WAS INSERTED BUT COULD NOT GET EITHER ADAPTER TO SEAT INTO THE SPACER. BOTH COULD BE EASILY PULLED FROM THE SUTURECUP. THE SURGEON DID NOT WANT TO ATTEMPT THE REMOVAL OF THE CUP AND OR STEM; DUE TO CONCERNS ABOUT FRACTURING THE PATIENT¿S HUMERUS. IT WAS DECIDED TO STOP THE PROCEDURE AND CLOSE THE PATIENT. THE PATIENT WAS REFERRED TO ANOTHER SURGEON SPECIALIZING IN REVISION SURGERIES. THIS WAS DISCOVERED DURING A CONVERSION SURGERY FROM RTSA TO CA HUMERAL HEAD. THE SALES REPRESENTATIVE REPORTS THE GLENOSPHERE, BASEPLATE, AND CENTRAL SCREW WERE REMOVED. ONE OF THE BASEPLATE SCREWS BROKE PRIOR TO REMOVAL. THE POLY LINER WAS ALSO REMOVED FROM THE SUTURECUP. ADDITIONAL INFORMATION RECEIVED ON 3/27/2024: THE PATIENT UNDERWENT THE ORIGINAL PROCEDURE ON (B)(6) 2024. A SCREW BROKE POST-OPERATIVE AND BECAUSE OF MOVEMENT, IT CAUSED THE BASEPLATE AND THE CENTRAL SCREW TO BECOME LOOSE. BOTH SURGERIES WERE PERFORMED BY THE SAME SURGEON AT THE SAME FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406562 REVERS 36MM CA ADAPTER ASSEMBLY SHOULDR PROSTH HEMI- HUM UNCEM HSD ARTHREX, INC. REVERS 36MM CA ADAPTER ASSEMBLY 22.02140 00888867230378

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other