BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ22

    MDR report key: 7596016 · Received June 13, 2018

    Report

    Report Number
    3005180920-2018-00419
    Event Type
    Injury
    Date Received
    June 13, 2018
    Date of Event
    May 14, 2018
    Report Date
    June 13, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706551
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 JUNE 2018. LOT 174726: 73 ITEMS MANUFACTURED AND RELEASED ON 08 NOVEMBER 2017. EXPIRATION DATE: 2022-10-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 5 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM REFERENCE (B)(4); LOT 173417: 78 ITEMS MANUFACTURED AND RELEASED ON 27 JUNE 2017. EXPIRATION DATE: 2022-06-08; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 45 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VISUAL INSPECTION PERFORMED BY R&D PRODUCT MANAGER ON (B)(4) 2018 THE VISUAL INSPECTION CONFIRMS THAT THE GLENOSPHERE REPORTS SCRATCHES ON THE ARTICULAR SURFACE. NO SIGNS OF BREAKAGE ARE VISIBLE ON THE OUTER BORDER OF THE REVERSE LINER. NO ROOT CASE CAN BE IDENTIFIED ON THE INVESTIGATED IMPLANTS CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON (B)(4) 2018 RECURRENT DISLOCATION OF REVERSE SHOULDER ARTHROPLASTY 3 MONTHS AFTER PRIMARY IMPLANTATION. THIS EVENT MAY BE DUE TO SOFT TISSUE DEFICIENCY , RESULTING IN FAILURE TO PROVIDE SUFFICIENT STABILITY. THE INSERT WAS EXCHANGED TO A THICKER ONE TO RECREATE SOFT TISSUE TENSION. THE IMPLANTED COMPONENTS DID NOT MOBILIZE, NOR DID THEY FAIL IN ANY WAY. NO INFORMATION ON THE ORIGIN OF SCRATCHES ON THE GLENOSPHERE IS AVAILABLE.

    Description of Event or Problem · 1

    REVISION 3 MONTHS AFTER PRIMARY DUE TO RECURRENT DISLOCATIONS; PRIMARY SURGERY PERFORMED ON (B)(6) 2018. THE SURGEON REVISED THE 36/0 LINER (IN POSITION 145°) WITH A 36/+3 LINER (IN POSITION 155°) TO OBTAIN A GOOD STABILITY. HE ALSO REVISED THE GLENOSPHERE AS IT HAD A SLIGHT SCRATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438379 REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ22 GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 174726 07630040706551

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention