BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X15

    MDR report key: 9346680 · Received November 20, 2019

    Report

    Report Number
    3005180920-2019-00967
    Event Type
    Injury
    Date Received
    November 20, 2019
    Date of Event
    October 22, 2019
    Report Date
    December 11, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706414
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER ON 31ST OF OCTOBER 2019 EARLY INFECTION IN REVERSE SHOULDER ARTHROPLASTY, 1 MONTH AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING RSA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. ON 25-NOVEMBER-2019 WE WERE INFORMED THAT THE KIND OF PATHOGEN IS: CUTIBACTERIUM ACNES ET STAPHYLOCOQUE EPIDERMIDIS.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED 1 MONTH AFTER THE PRIMARY DUE TO AN INFECTION. THE PATHOGEN IS CUTIBACTERIUM ACNES ET STAPHYLOCOQUE EPIDERMIDIS. ALL IMPLANTS WERE REVISED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 28 OCTOBER 2019. LOT 184562: 85 ITEMS MANUFACTURED AND RELEASED ON 17-APR-2019. EXPIRATION DATE: 2024-04-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 29 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 28 OCTOBER 2019. REVERSE SHOULDER SYSTEM 04.01.0163 GLENOID POLYAXIAL LOCKING SCREW L38 (K170452) LOT. 174749. LOT 174749: 150 ITEMS MANUFACTURED AND RELEASED ON 30-GEN-2018. EXPIRATION DATE: 2023-01-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 74 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452) LOT. 182475. LOT 182475: 450 ITEMS MANUFACTURED AND RELEASED ON 04-SEP-2018. EXPIRATION DATE: 2023-08-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 370 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27 (K170452) LOT. 179114. LOT 179114: 122 ITEMS MANUFACTURED AND RELEASED ON 26-MAR-2018. EXPIRATION DATE: 2023-03-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 48 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0008 STD HUMERAL DIAPHYSIS CEMENTLESS - 13 (K170452) LOT. 17647. LOT 176472: 80 ITEMS MANUFACTURED AND RELEASED ON 27-FEB-2018. EXPIRATION DATE: 2023-02-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 31 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0°(K170452) LOT. 1810996. LOT 1810996: 154 ITEMS MANUFACTURED AND RELEASED ON 11-APR-2019. EXPIRATION DATE: 2024-03-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 142 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0123 HUMERAL REVERSE HC LINER Ø39/+3MM (K170452) LOT. 179980 LOT 179980: 56 ITEMS MANUFACTURED AND RELEASED ON 02-MAY-2018. EXPIRATION DATE: 2023-04-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 35 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 1 MONTH AFTER THE PRIMARY DUE TO AN INFECTION. THE PATHOGEN IS UNKNOWN AT THIS MOMENT. ALL IMPLANTS WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145494 REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X15 REVERSE SHOULDER SYSTEM GLENOID BASEPLATE PHX MEDACTA INTERNATIONAL SA 184562 07630040706414

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention