BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 19574220 · Received June 20, 2024

    Report

    Report Number
    1038671-2024-02035
    Event Type
    Injury
    Date Received
    June 20, 2024
    Date of Event
    May 28, 2024
    Report Date
    October 15, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086389
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM 320-20-38 S301782. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM 320-20-26 S295194. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM 320-20-34 S304912. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM 300-01-13 5512132. EQ REV LOCKING SCREW 320-15-05 7110980. EQUINOXE REVERSE 38MM HUMERAL LINER +2.5 320-38-03 S259336. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 320-10-00 7046253. EQ REVERSE TORQUE DEFINING SCREW KIT 320-20-00 6942895. EQ REV GLENOID PLATE 320-15-01 7074989. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM 320-20-34 S304889. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM 320-20-38 S247792.

    Additional Manufacturer Narrative · 0

    H3: ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT UNDERWENT A LEFT REVERSE SHOULDER REPLACEMENT SURGERY ON (B)(6) 2021. ON (B)(6) 2024, APPROXIMATELY 2 YEARS AND 7 MONTHS POST INDEX SURGERY, THE PATIENT WAS REVISED ¿DUE TO INSTABILITY.¿ THE GLENOSPHERE, HUMERAL LINER, AND HUMERAL TRAY COMPONENTS WERE REPLACED. THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND NO IMAGES OR RADIOGRAPHS WERE PROVIDED. PER THE EQUINOXE IFU (700-096-060 REV R), AS PART OF THE PRE-OPERATIVE ASSESSMENT, THE SURGEON MUST ENSURE THAT NO BIOLOGICAL, BIOMECHANICAL, OR OTHER FACTORS EXIST THAT MIGHT ADVERSELY AFFECT THE SURGERY AND/OR POSTOPERATIVE PERIOD. LONGEVITY OF THE IMPLANT DEPENDS ON THE WEIGHT AND ACTIVITY LEVEL OF THE PATIENT, PATIENT MORTALITY, OR NEED FOR COMPONENT REPLACEMENT SECONDARY TO PATIENT WEIGHT AND ACTIVITY LEVEL. DURING SURGERY AND PRIOR TO CLOSURE, RANGE OF MOTION SHOULD BE USED TO VERIFY STABILITY AND TENSION OF THE JOINT. A TOO LAX OR TOO TIGHT JOINT MAY LEAD TO INSTABILITY OR ROTATOR CUFF RUPTURE. FAILURE OF THE SUBSCAPULARIS REPAIR MAY LEAD TO INSTABILITY OR LOSS OF FUNCTION. EXTREME CARE IN PATIENT HANDLING (E.G., MOVING PATIENT, CHANGING CLOTHES, ETC.) IMMEDIATELY AFTER SURGERY IS ALSO NECESSARY. EXCESSIVE ACTIVITY AND TRAUMA AFFECTING JOINT REPLACEMENTS HAVE BEEN ASSOCIATED WITH PREMATURE FAILURE. ALL PATIENTS SHOULD BE INSTRUCTED ON THE LIMITATIONS OF THE PROSTHESIS AND THE POSSIBILITY OF SUBSEQUENT SURGERY. THE PATIENT SHOULD BE CAUTIONED TO MONITOR ACTIVITIES AND PROTECT THE REPLACED JOINT FROM UNREASONABLE STRESSES AND FOLLOW THE WRITTEN INSTRUCTIONS OF THE PHYSICIAN WITH RESPECT TO FOLLOW-UP CARE AND TREATMENT. THE PATIENT SHOULD BE WARNED AGAINST UNASSISTED ACTIVITY, PARTICULARLY IN LIFTING, AND THAT ACTIVE MOTION SHOULD NOT BE INITIATED UNTIL RECOMMENDED BY THE SURGEON IN ORDER TO ENSURE SUBSCAPULARIS HEALING IS COMPLETE. PATIENTS MUST BE INFORMED THAT THEIR WEIGHT AND ACTIVITY LEVEL MAY AFFECT THE LONGEVITY OF THE IMPLANT. PATIENTS SHOULD BE ADVISED TO REPORT ANY PAIN, DECREASE IN RANGE OF MOTION, SWELLING, FEVER, OR UNUSUAL SOUNDS AS THIS MAY INDICATE POSITIONAL CHANGES IN THE IMPLANT THAT COULD LEAD TO PREMATURE FAILURE. DEVICE SPECIFIC RISK INCLUDE FRACTURE, MIGRATION, LOOSENING, SUBLUXATION, OR DISLOCATION OF THE PROSTHESIS OR ANY OF ITS COMPONENTS, ANY OF WHICH MAY REQUIRE A SECOND SURGICAL INTERVENTION OR REVISION. ADDITIONALLY, POSSIBLE REASONS FOR INSTABILITY ARE CAPTURED IN THE RISK ASSESSMENT AND CONTROLS REPORT, RACR-000203 REV J. "SOFT-TISSUE IMBALANCE IS PRESENT IN MOST CASES OF INSTABILITY FOLLOWING SHOULDER ARTHROPLASTY, AND COMPONENT MALPOSITIONING PLAYS AN ADDITIONAL ROLE IN SOME CASES. MORE THAN ONE-HALF OF THE SHOULDERS IN THE PRESENT STUDY REMAINED UNSTABLE DESPITE ATTEMPTS AT REVISION. SURGICAL TREATMENT OF INSTABILITY FOLLOWING ARTHROPLASTY IS ASSOCIATED WITH ONLY A MODEST SUCCESS RATE." SANCHEZ-SOTELO, JOAQUIN MD, PHD; SPERLING, JOHN W. MD; ROWLAND, CHARLES M. MS; COFIELD, ROBERT H. MD. INSTABILITY AFTER SHOULDER ARTHROPLASTY: RESULTS OF SURGICAL TREATMENT. THE JOURNAL OF BONE & JOINT SURGERY 85(4):P 622-631, APRIL 2003. ¿THERE ARE SEVERAL CONTRIBUTING FACTORS THAT CAN LEAD TO DISLOCATION OR INSTABILITY: LACK OF SOFT TISSUE TENSION, MECHANICAL IMPINGEMENT, MISMATCH OF THE GLENOSPHERE AND HUMERAL SOCKET, AND IMPROPER VERSION OF THE PROSTHESIS.¿ FROM:HTTPS://WWW.NCBI.NLM.NIH.GOV/PMC/ARTICLES/PMC4596185/#:~:TEXT=THERE%20 ARE%20 SEVERAL%20 CONTRIBUTING%20 FACTORS,STABILITY%20 OF%20 THE%20 REVERSE%20 SHOULDER. THE CAUSE OF THE PATIENT¿S SHOULDER INSTABILITY AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE, IMPLANT POSITIONING, AND/OR IMPLANT SIZE SELECTION. INSTABILITY IS A KNOWN HARM, AS OUTLINED IN THE IFU AND RISK FILE. CORRECTION: D1 BRAND NAME, H6 CLINICAL CODE. PLEASE DISREGARD ALL PREVIOUSLY REPORTED PRODUCT INFORMATION IN SECTION D. PLEASE DISREGARD 510K IN G4. PLEASE DISREGARD H4 MANUFACTURING DATE. CORRECTION: D10: 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM 320-20-38 S301782. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM 320-20-26 S295194. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM 320-20-34 S304912. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM 300-01-13 5512132. EQ REV LOCKING SCREW 320-15-05 7110980. EQUINOXE REVERSE 38MM HUMERAL LINER +2.5 320-38-03 S259336. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 320-10-00 7046253. EQ REVERSE TORQUE DEFINING SCREW KIT 320-20-00 6942895. EQ REV GLENOID PLATE 320-15-01 7074989. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM 320-20-34 S304889. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM 320-20-38 S247792.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 2 YEARS AND 7 MONTHS POST INITIAL LEFT TSA, THE PATIENT WAS REVISED DUE TO INSTABILITY. THE LINER WAS EXCHANGED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER MEDICAL HISTORY/PATIENT INFORMATION PROVIDED. THE EXPLANT WAS DISCARDED. 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE SERIAL: (B)(6). 510K: K063569. UDI: (B)(4). PRODUCT CODE: KWT. CONCOMITANTS: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM 320-20-38 S301782. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM 320-20-26 S295194. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM 320-20-34 S304912. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM 300-01-13 5512132. EQ REV LOCKING SCREW 320-15-05 7110980. EQUINOXE REVERSE 38MM HUMERAL LINER +2.5 320-38-03 S259336. ***S259336 IS AFFECTED BY THE RECALL. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 320-10-00 7046253. EQ REVERSE TORQUE DEFINING SCREW KIT 320-20-00 6942895. EQ REV GLENOID PLATE 320-15-01 7074989. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM 320-20-34 S304889. EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM 320-20-38 S247792.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512068 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086389

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention SEE H11.