BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 14

    MDR report key: 12406281 · Received September 1, 2021

    Report

    Report Number
    3005180920-2021-00705
    Event Type
    Injury
    Date Received
    September 1, 2021
    Date of Event
    August 9, 2021
    Report Date
    September 1, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040715959
    PMA / PMN Number
    K180089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW WAS PERFORMED ON 12.AUGUST.2021: LOT 1906557: 12 ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2019. EXPIRATION DATE: 2024-09-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 6 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 1908177 BATCH REVIEW WAS PERFORMED ON 12.AUGUST.2021: LOT 1908177: 149 ITEMS MANUFACTURED AND RELEASED ON 24-FEB-2020. EXPIRATION DATE: 2025-02-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 148 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0123 HUMERAL REVERSE HC LINER Ø39/+3MM (K170452) LOT. 1907767 BATCH REVIEW WAS PERFORMED ON 12.AUGUST.2021: LOT 1907767: 56 ITEMS MANUFACTURED AND RELEASED ON 31-OCT-2019. EXPIRATION DATE: 2024-10-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 49 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0154 GLENOID BASEPLATE Ø27X15 (K170452) LOT. 1908237 BATCH REVIEW WAS PERFORMED ON 12.AUGUST.2021: LOT 1908237: 80 ITEMS MANUFACTURED AND RELEASED ON 19-FEB-2020. EXPIRATION DATE: 2025-02-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0161 GLENOID POLYAXIAL LOCKING SCREW - L30 (K170452) LOT. 1906607 BATCH REVIEW WAS PERFORMED ON 12.AUGUST.2021: LOT 1906607: 250 ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2019. EXPIRATION DATE: 2024-09-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 243 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27 (K170452) LOT. 1908174 BATCH REVIEW WAS PERFORMED ON 12.AUGUST.2021: LOT 1908174: 63 ITEMS MANUFACTURED AND RELEASED ON 15-JAN-2020. EXPIRATION DATE: 2025-01-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 61 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0164 GLENOID POLYAXIAL LOCKING SCREW - L42 (K170452) LOT. 184572 BATCH REVIEW WAS PERFORMED ON 12.AUGUST.2021: LOT 184572: 107 ITEMS MANUFACTURED AND RELEASED ON 25-APR-2019. EXPIRATION DATE: 2024-04-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 42 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    1-YEAR AND 5 MONTHS AFTER THE PRIMARY SURGERY THE SURGEON REVISED ALL IMPLANTS DUE TO INFECTION OF BACTERIA (PROPIONIBACTERIUM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308900 REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 14 CEMENTLESS SHOULDER DIAPHYSIS PHX MEDACTA INTERNATIONAL SA 1906557 07630040715959

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention