MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ24.5; SHOULDER GLENOSPHERE

Catalog Number	04.01.0208
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 october 2023: lot 2240583: (b)(4) items manufactured and released on 05-dec-2022.Expiration date: 2027-11-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical analysis performed by medical affairs department: revision after 11 days that was a result of a former revision rsa.The first revision was due to impingement and the second one is caused by dislocation after lifting a heavy weight.It may be possible that since not much time has passed from the first revision the luxation may be caused by insufficient re-establishment of soft tissue tension after the operation.No further conclusion can be drawn with the elements at hand.Other implant involved, batch review performed on 18 october 2023: reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm (k170452) lot 2241371: (b)(4) items manufactured and released on 03-jan-2023.Expiration date: 2027-12-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
The patient had a primary shoulder surgery on (b)(6) 2022.On (b)(6) 2023, the patient came in for a post-op appointment and it was observed that the patient was experiencing impingement of the glenosphere on the scapula with scapula notching.The cause of this occurrence is unknown.The surgeon revised the glenosphere, metaphysis, and liner.The surgery was completed successfully.Presently, on (b)(6) 2023, the patient came reporting pain due to shoulder luxation after lifting a heavy weight.The surgeon removed the glenosphere, liner, metaphysis, glenoid baseplate and repositioned the baseplate more inferior on the glenoid.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ24.5
• Common Device Name: SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18128714
• Report Number: 3005180920-2023-00868
• Device Sequence Number: 7715081
• Product Code: HSD
• UDI-Device Identifier: 07630040728072
• UDI-Public: 07630040728072
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2023

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 Catalogue Number: 04.01.0208
• Device Lot Number: 2240583
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male