MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 36X24.5

Model Number 04.01.0169

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 09/25/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 20-oct-2020: lot 179110: (b)(4) items manufactured and released on 28-mar-2018.Expiration date: 14-mar-2023.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Visual inspection was performed by r&d project manager: the glenosphere shows two mild circular markings on the backsurface presumably due to friction with two protruding screws.The outer surfaces of glenosphere screw are partially polished.This is deemed to be caused by friction with the inner recess of the glenosphere after implant mobilization.The pe liner is massively damaged due to friction with the scapula after mobilization of the glenosphere.The inner screw of the polyaxial locking screw is partially damaged.In details the superior rim is deformed downwards indicatively along 150°.The root cause of such a deformation is determined to be the contact with the glenosphere backsurface, which may have occurred due to a proud positioning of the screw during the primary surgery or backing of the screw after the primary surgery.Other devices involved in the event: reverse shoulder system 04.01.0159 glenoid polyaxial locking screw - l22 lot.179970 (k170452).Batch review performed on 20-oct-2020: lot 179970: (b)(4) items manufactured and released on 17-may-2018.Expiration date: 06-may-2023.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Reverse shoulder system 04.01.0151 glenoid baseplate ø24.5x15 lot.1810997 (k170452) batch review performed on 20-oct-2020.Lot 1810997: (b)(4) items manufactured and released on 15-feb-2019.Expiration date: 06-feb-2024.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.

Event Description

Revision surgery performed due to glenosphere dissociation from the baseplate 1 year and 3 months after the primary.During the revision surgery one of the locking screw was proud from the glenoid baseplate and the surgeon tried to screw it again but the head of the screw broke.

Manufacturer Narrative

Clinical evaluation: dissociation of glenosphere from the glenoid baseplate in rsa few weeks after primary surgery.According to the report, one of the baseplate fixing screws was found to be proud from the baseplate.Such condition is known to prevent full seating of the glenosphere on the baseplate and therefore the self-unscrewing of the glenosphere fixation screw becomes quite likely.The possibility that the glenoid fixation screw moved after being inserted is of course existing but cannot be verified at this stage.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 36X24.5
• Type of Device: GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10717728
• MDR Text Key: 212475891
• Report Number: 3005180920-2020-00732
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706568
• UDI-Public: 07630040706568
• Combination Product (y/n): Y
• PMA/PMN Number: K170452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2023
• Device Model Number: 04.01.0169
• Device Catalogue Number: 04.01.0169
• Device Lot Number: 179110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention