MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5; REVERSE GLENOSPHERE

Catalog Number 04.01.0169

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem Joint Disorder (2373)

Event Date 11/28/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 6 december 2019.Lot 189744: (b)(4) items manufactured and released on 12-mar-2019.Expiration date: 2024-03-02.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 events.Additional implant involved: reverse shoulder system 04.01.0151 glenoid baseplate ø24.5x15 (k170452) lot.1904752.Batch review performed on 6 december 2019.Lot 1904752: (b)(4) items manufactured and released on 12-sep-2019.Expiration date: 2024-09-01.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 events.Clinical evaluation performed by medical affairs director.Few days after primary rsa the glenoid component dislocated and the scapular bone was fractured.This is most probably due to the weak quality of the bone.The implants seem to have been correctly positioned and there is no discernible hint of a device malfunction.

Event Description

Additional surgery performed 7 days after the primary due to dislocation of the baseplate and breakage of the posterior halve portion of the glenoid.The patient has a weak bone.No information if it was caused by trauma.The glenoid baseplate, liner, screws and metaphysis were explanted without implanting new implants.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5
• Type of Device: 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: 9494238
• MDR Text Key: 174477629
• Report Number: 3005180920-2019-01075
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706568
• UDI-Public: 07630040706568
• 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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2024
• Device Catalogue Number: 04.01.0169
• Device Lot Number: 189744
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/19/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/12/2019
• 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
• Patient Weight: 55