MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 42X27; SHOULDER GLENOSPHERE

Model Number	04.01.0174
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 october 2020: lot 188492: (b)(4) items manufactured and released on 27-jun-2019.Expiration date: 2024-06-12.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.Additional item involved in the event, batch review performed on 06 october 2020: reverse shoulder system 04.01.0154 glenoid baseplate ø27x15 (k170452) lot.1904754 lot 1904754: (b)(4) items manufactured and released on 25-sep-2019.Expiration date: 2024-09-15.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 or Problem Description
A mss inverse operation took place on (b)(6) 2020.The operation went quite well so far.On (b)(6) 2020 the patient came to the consultation hour with the dissociated glenosphere from the baseplate.One week before, the patient had also been to the consultation and everything was fine and the patient was very satisfied.Glenosphere revised 1 month after primary.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: few weeks after rsa the glenosphere is found dissociated from the baseplate.Among the reasons that may have led to this accident, one possibility is that one of the baseplate fixation screws was proud from the baseplate and prevented full seating of the glenosphere during impaction.However, other causes may have prevented full engagement of the taper spigot, such as presence of tissue between surfaces or suboptimal alignment.No final conclusion can be reached with the information at hand.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 42X27
• Common Device Name: SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10710584
• Report Number: 3005180920-2020-00728
• Device Sequence Number: 3907478
• Product Code: PHX
• UDI-Device Identifier: 07630040706612
• UDI-Public: 07630040706612
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2024
• Device Model Number: 04.01.0174
• Device Catalogue Number: 04.01.0174
• Device Lot Number: 188492
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention