MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ27; SHOULDER REVERSE GLENOSPHERE

Catalog Number 04.01.0173

Device Problem Device Slipped (1584)

Patient Problem Joint Dislocation (2374)

Event Date 04/11/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 06 may 2019: lot 174737: (b)(4) items manufactured and released on 11-jan-2018.Expiration date: 2022-12-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event (mdr2019-00022).Additional implant involved: reverse shoulder system 04.01.0123 humeral reverse hc liner ø39/+3mm (k170452) , lot 184048: (b)(4) items manufactured and released on 26-jun-2018.Expiration date: 2023-06-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director: dislocation of a rsa is a possible adverse event following surgery.It is normally due to insufficient tension or strength of the rotator cuff and other soft tissues surrounding the joint, or it could be due to traumatic events or consequences of unfavourable efforts.Better tension can be achieved with a thicker/slanted humeral insert.This revision operation was not caused by a problem with the implanted device.

Event Description

On (b)(6) 2019 we were informed about a revision surgery performed on the following day, 4 months after the primary due to shoulder implant luxation.Metaphysis, inlay and glenosphere have been changed.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ27
• Type of Device: SHOULDER REVERSE GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8599633
• MDR Text Key: 144703282
• Report Number: 3005180920-2019-00357
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706605
• UDI-Public: 07630040706605
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K170452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/27/2022
• Device Catalogue Number: 04.01.0173
• Device Lot Number: 174737
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention