BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25

    MDR report key: 19078274 · Received April 10, 2024

    Report

    Report Number
    3005180920-2024-00205
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    March 13, 2024
    Report Date
    April 10, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706421
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 26 MARCH 2024. LOT 2209636: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEP-2022. EXPIRATION DATE: 2027-AUG-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. PRELIMINARY ANALYSIS PERFORMED BY R&D PROJECT MANAGER. THE PICTURE OF THE EXPLANTS CONFIRMS THAT AT LEAST ONE SCREW IS BROKEN. GIVEN THE ORIENTATION OF THE PICTURE, IT IS NOT POSSIBLE TO CONFIRM THE BREAKAGE OF THE SECOND ONE. THE FAILURE OF THE BONE GRAFT RESULTED IN THE SCREW OVERLOADING WITH SUBSEQUENT BREAKAGE. NO ACTION IS SUGGESTED. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT REVISION SURGERY 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY DUE TO THE GLENOID BASEPLATE MOBILIZATION. ACCORDING TO THE REPORT, THE BONE GRAFT HAD NOT OSSEOINTEGRATED. FROM THE RADIOGRAPHIC IMAGES, TWO GLENOID POLYAXIAL LOCKING SCREWS ARE VISIBLY BROKEN, ALMOST CERTAINLY BECAUSE OF THE GRAFT FAILURE TO OSSEOINTEGRATE. THE SURGEON DECIDED TO GRAFT WITH SOME ILIAC CREST BONE THE GLENE AND WAIT FOR OSSEOINTEGRATION OF THIS ONE IMPLANTING A HEMIARTHROPLASTY. THEREFORE, THERE IS NO REASON TO SUSPECT A FAULTY DEVICE. ADDITIONAL COMPONENTS INVOLVED, BATCH REVIEW PERFORMED ON 26 MARCH 2024: REVERSE SHOULDER SYSTEM 04.01.0162 GLENOID POLYAXIAL LOCKING SCREW - L34 (K170452) LOT. 2214353 LOT 2214353: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2022. EXPIRATION DATE: 2027-AUG-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0159 GLENOID POLYAXIAL LOCKING SCREW - L22 (K170452) LOT. 2210985 LOT 2210985: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2022. EXPIRATION DATE: 2027-JUN-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0160 GLENOID POLYAXIAL LOCKING SCREW - L26 (K170452) LOT. 2002442 LOT 2002442: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUL-2020. EXPIRATION DATE: 2025-JUN-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0199 GLENOID POLYAXIAL NON-LOCKING SCREW - L34 (K181826) LOT. 2217149 LOT 2217149: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEP-2022. EXPIRATION DATE: 2027-AUG-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ABOUT 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY. THE GLENOID BASEPLATE WAS MOBILIZED BECAUSE THE BONE GRAFT HAD NOT OSSEOINTEGRATED. TWO GLENOID POLYAXIAL LOCKING SCREWS WERE FOUND BROKEN. THE SURGEON GRAFTED THE GLENE WITH SOME ILLIAC CREST BONE AND CONVERTED INTO AN HEMI-ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412151 REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25 GLENOID BASEPLATE PHX MEDACTA INTERNATIONAL SA 2209636 07630040706421

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention