BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM

    MDR report key: 16020606 · Received December 21, 2022

    Report

    Report Number
    3005180920-2022-00941
    Event Type
    Injury
    Date Received
    December 21, 2022
    Date of Event
    November 21, 2022
    Report Date
    February 21, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706261
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2022. LOT 2201465: 84 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2022. EXPIRATION DATE: 2027-04-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 37 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON (B)(6) 2022. REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER Ø36/+0MM (K170452) LOT 2212972: 60 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2022. EXPIRATION DATE: 2027-08-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 36 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: REVISION 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT WAS REVISED BECAUSE OF A POSTERIOR SHOULDER DISLOCATION. THE SURGEON SUCCESSFULLY REVISED THE GLENOSPHERE AND THE LINER. THE COMPONENTS REMAINED INTACT AND WE CANNOT DETECT ANY HINT OF A DEFECT THAT LED TO THE PROBLEM. THESE EVENTS ARE NORMAL ORIGINATED BY PROGRESSION OF DISEASE TO THE SOFT TISSUES OR INSUFFICIENT RE-ESTABLISHMENT OF SOFT TISSUE TENSION AFTER THE OPERATION. NO FURTHER CONCLUSION CAN BE DRAWN WITH THE ELEMENTS AT HAND.

    Additional Manufacturer Narrative · 0

    THE INFORMATION OF THE LOT WERE UPDATED, THE INFORMATION WERE RECEIVED ON 22 DECEMBER 2022. BATCH REVIEW PERFORMED ON 20-DEC-2022. LOT 2207932: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUN-2022. EXPIRATION DATE: 2027-05-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: THE ARTICULAR SURFACE OF THE GLENOSPHERE IS PARTIALLY DULL, LIKELY DUE TO FRICTION WITH THE HUMERAL IMPLANT AFTER SHOULDER DISLOCATION. THE GLENOSPHERE SCREW DOES NOT PRESENT ANY SIGNS OF DAMAGE. THE LINER HAS FEW SCRATCHES, PROBABLY OCCURRED DURING THE REVISION SURGERY.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT WAS REVISED BECAUSE OF A POSTERIOR SHOULDER DISLOCATION. THE SURGEON SUCCESSFULLY REVISED THE GLENOSPHERE AND THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2143199 REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM REVERSE HC LINER PHX MEDACTA INTERNATIONAL SA 04.01.0172 2207932 07630040706261

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention