BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 42XØ27

    MDR report key: 12631996 · Received October 14, 2021

    Report

    Report Number
    3005180920-2021-00800
    Event Type
    Injury
    Date Received
    October 14, 2021
    Date of Event
    September 14, 2021
    Report Date
    November 9, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSD
    UDI-DI
    07630040728119
    PMA / PMN Number
    K193175
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION: FEW MONTHS AFTER PRIMARY RSA THE GLENOSPHERE IS FOUND DETACHED FROM THE BASEPLATE. THIS IS PROBABLY DUE TO A PROUD BASEPLATE FIXATION SCREW THAT PREVENTED THE GLENOSPHERE FROM REACHING FINAL SEATING POSITION AND ENGAGING THE MORSE TAPER ON THE BASEPLATE. WE CANNOT DETERMINE HOW OR WHEN THIS ORIGINATED: IT'S RATHER PROBABLE THAT THE BASEPLATE FIXATION SCREW WAS IMPEDED TO REACH FINAL POSITION FOR SOME UNKNOWN REASON SINCE THE TIME OF PRIMARY SURGERY. WE DO NOT IDENTIFY A CLINICAL CAUSE TO THIS ADVERSE EVENT. ONCE PROPERLY REPLACED, NO FURTHER CLINICAL CONSEQUENCE SHOULD BE EXPECTED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 SEPTEMBER 2021: LOT 1910958: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2020. EXPIRATION DATE: 2025-05-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0193 THREADED GLENOID BASEPLATE Ø27X35 (K171058) LOT. 185296. BATCH REVIEW PERFORMED ON 14 OCTOBER 2021. LOT 185296: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-AUG-2018. EXPIRATION DATE: 2023-08-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: IN THE PROVIDED X.-RAYS THE GLENOSPHERE APPEARS TO BE DISSOCIATED FROM THE BASEPLATE AND THE SCREW LOOSE AND PARTIALLY OUT OF ITS INTENDED POSITION. AN ANALYSIS OF THE EXPLANTS IS REQUIRED TO PROCEED WITH THE RESEARCH OF THE ROOT CAUSE. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: MILD CIRCUMFERENTIAL SIGNS ARE VISIBLE ON THE FLAT BACKSURFACE OF THE GLENOSPHERE, PROBABLY DUE TO FRICTION WITH A PERIPHERAL GLENOID SCREW. IT IS NOT POSSIBLE TO STATE WHETHER THE SCREW WAS POSITIONED PROUD FORM THE BASEPLATE AFTER THE PRIMARY SURGERY OR IT BACKED OUT IN THE FOLLOWING MONTHS. THE LINER IS DAMAGED ON THE OUTER RIM OF THE ARTICULAR SURFACE, LIKELY DUE TO FRICTION WITH THE SCAPULA PRIOR TO OR AFTER THE GLENOSPHERE DISSOCIATION. NO ACTION IS SUGGESTED.

    Description of Event or Problem · 1

    AT 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND A GRINDING FEELING IN THE SHOULDER. THE SURGEON TOOK X-RAYS AND IT WAS DETERMINED THAT GLENOSPHERE SCREW AND IMPLANT WERE LOOSE. THE SURGEON REVISED THE LATERALIZED GLENOSPHERE AND THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528592 REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 42XØ27 REVERSE SHOULDER GLENOSPHERE HSD MEDACTA INTERNATIONAL SA 04.01.0212 1910958 07630040728119

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention