BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 12

    MDR report key: 12427665 · Received September 6, 2021

    Report

    Report Number
    3005180920-2021-00707
    Event Type
    Injury
    Date Received
    September 6, 2021
    Date of Event
    August 9, 2021
    Report Date
    September 6, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040715935
    PMA / PMN Number
    K180089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 10.AUGUST.2021. LOT 172590: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAY-2017. EXPIRATION DATE: 2022-MAY-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED: REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° (K170452) LOT. 184049. LOT 184049: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3-JAN-2019. EXPIRATION DATE: 2023-DEC-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0119 HUMERAL REVERSE HC LINER Ø36/+0MM (K170452) LOT. 175043. LOT 175043: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-SEP-2017. EXPIRATION DATE: 2022-SEP-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0151 GLENOID BASEPLATE Ø24.5X15 (K170452) LOT. 175029. LOT 175029: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DEC-2017. EXPIRATION DATE: 2022-NOV-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0169 GLENOSPHERE 36XØ24.5 (K170452) LOT. 179109. LOT 179109: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2018. EXPIRATION DATE: 2023-MAR-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0157 GLENOID POLYAXIAL LOCKING SCREW - L14 (K170452) LOT. 183687. LOT 183687: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-SEP-2018. EXPIRATION DATE: 2023-SEP-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0158 GLENOID POLYAXIAL LOCKING SCREW - L18 (K170452) LOT. 174281. LOT 174281: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-NOV-2017. EXPIRATION DATE: 2022-NOV-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT (IT DID NOT LEAD TO A REVISION SURGERY).

    Description of Event or Problem · 1

    2 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327935 REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 12 REVERSE SHOULDER HUMERAL DIAPHYSIS CEMENTLESS PHX MEDACTA INTERNATIONAL SA 172590 07630040715935

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention