BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 36X24.5

    MDR report key: 11503226 · Received March 17, 2021

    Report

    Report Number
    3005180920-2021-00204
    Event Type
    Injury
    Date Received
    March 17, 2021
    Date of Event
    February 15, 2021
    Report Date
    March 17, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706568
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 FEBRUARY 2021: LOT 1811894: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MAY-2019. EXPIRATION DATE: 2024-05-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0151 GLENOID BASEPLATE Ø24.5X15 (K170452) LOT. 1811888. BATCH REVIEW PERFORMED ON 22 FEBRUARY 2021: LOT 1811888: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-MAY-2019. EXPIRATION DATE: 2024-04-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH TWO OTHER SIMILAR EVENTS REPORTED. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER Ø36/+0MM (K170452) LOT. 1901915. BATCH REVIEW PERFORMED ON 22 FEBRUARY 2021: LOT 1901915: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUNE-2019. EXPIRATION DATE: 2024-05-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0159 GLENOID POLYAXIAL LOCKING SCREW - L22 (K170452) LOT. 182474. BATCH REVIEW PERFORMED ON 22 FEBRUARY 2021: LOT 182474: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-SEP-2018. EXPIRATION DATE: 2023-08-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0160 GLENOID POLYAXIAL LOCKING SCREW - L26 (K170452) LOT. 1811901. BATCH REVIEW PERFORMED ON 22 FEBRUARY 2021: LOT 1811901: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MARCH-2019. EXPIRATION DATE: 2024-03-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: THE X-RAYS CONFIRM THE DISSOCIATION OF THE GLENOSPHERE FROM THE GLENOID BASEPLATE AND LOOSENING OF THE GLENOSPHERE SCREW. THE REPORTED SIGNS OF METALLOSIS ARE LIKELY RELATED TO MOBILIZATION OF THE IMPLANTS. THE LINER APPEARS TO BE MASSIVELY DAMAGED, PROBABLY DUE TO FRICTION WITH THE SCAPULAR NECK AND TO THE IMPLANT REMOVAL. IT IS NOT CLEAR WHETHER THE CONVEX BACKSURFACE OF THE GLENOSPHERE IS DAMAGED. VISUAL INSPECTION IS RECOMMENDED TO PROCEED WITH THE ROOT CAUSE INVESTIGATION. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: THE GLENOSPHERE IS CONFIRMED TO HAVE CIRCULAR MARKINGS ON THE CONVEX BACKSURFACE, LIKELY DUE TO FRICTION WITH THE GLENOID POLYAXIAL SCREWS WHICH MAY HAVE BEEN POSITIONED PROUD FROM THE BASEPLATE OR MAY HAVE BACKED OFF FROM THEIR INTENDED POSITION. THE GLENOSPHERE SCREW HAS CIRCULAR MARKINGS CAUSED BY FRICTION WITH THE INNER RECESS OF THE IMPLANT. THE LINER IS MASSIVELY DAMAGED: THE SHAPE OF THE FAILURE SUGGESTS THAT THE LINER WAS CUT DURING THE REVISION SURGERY TO ALLOW FOR ITS REMOVAL. THE CHAMFER OF THE LINER IS WORN ON THE THIN SIDE, POSSIBLY DUE TO FRICTION WITH THE SCAPULA AFTER THE GLENOSPHERE DISSOCIATION. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: 1.3 YEARS AFTER RSA THE GLENOSPHERE FIXATION SCREW GETS LOOSE AND DAMAGES THE PE INSERT, ALSO CREATING SOME METALLOSIS. ACCORDING TO REPORT, ONE OF THE BASEPLATE FIXATION SCREWS BROKE IN THE BONE, ALTHOUGH WE WEREN'T ABLE TO DETECT THIS SITUATION FROM THE XRAYS SUPPLIED. IT'S THEREFORE POSSIBLE THAT THIS FRACTURE OF THE SCREW PREVENTED THE GLENOSPHERE TO REACH THE FINAL SEAT ON THE BASEPLATE SPIGOT AND THEREFORE THE GLENOSPHERE FIXATION SCREW COULD NOT BE FULLY TIGHTENED, BUT FROM THE INFORMATION SUPPLIED WE ARE UNABLE TO DRAW THIS CONCLUSION WITH CERTAINTY. SO WE CANNOT IDENTIFY A CLEAR ROOT CAUSE FOR THE SELF-UNSCREWING OF THE GLENOSPHERE FIXATION SCREW.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO THE DISSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE, THE GLENOSPHERE FIXATION SCREW LOOSENED. DURING THE REVISION SURGERY, THE SURGEON NOTICED THAT THE LINER WAS DEFORMED AND THE GLENOID POLYAXIAL LOCKING SCREW WAS BROKEN (IT IS UNCLEAR WHICH ONE BROKE). METALLOSIS WAS ALSO OBSERVED. THE SURGEON REVISED SUCCESSFULLY THE GLENOID POLYAXIAL LOCKING SCREWS, GLENOSPHERE, AND INSERT 1 YEAR 3 MONTHS AFTER THE PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398148 REVERSE SHOULDER SYSTEM GLENOSPHERE 36X24.5 REVERSE SHOULDER GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 04.01.0169 1811894 07630040706568

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention