MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 32XØ22; SHOULDER GLENOSPHERE

Model Number	04.01.0167
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 february 2020: lot 183536: (b)(4) items manufactured and released on 29-nov-2018.Expiration date: 2023-11-20.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 device involved: reverse shoulder system 04.01.0118 humeral reverse hc liner ø32/+6mm (k170452) lot 173416: (b)(4) items manufactured and released on 27-jun-2017.Expiration date: 2022-06-08.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.
Event or Problem Description
The patient came in reporting pain due to a dislocation of the poly from the glenosphere.The dislocation was due to the patient reaching for an object.The surgeon revised the glenosphere, humeral reverse metaphysis and humeral reverse hc liner 1 months and 8 days after primary.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 32XØ22
• Common Device Name: SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9870996
• Report Number: 3005180920-2020-00175
• Device Sequence Number: 13584438
• Product Code: PHX
• UDI-Device Identifier: 07630040706544
• UDI-Public: 07630040706544
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2020

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: 11/20/2023
• Device Model Number: 04.01.0167
• Device Catalogue Number: 04.01.0167
• Device Lot Number: 183536
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/24/2020
• 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