MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39X24.5; SHOULDER GLENOSPHERE

Model Number	04.01.0208
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 february 2021: lot 189939: (b)(4) items manufactured and released on 08-may-2019.Expiration date: 2024-04-24.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 batch review performed on 23 february 2021: reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm ((b)(4)) lot 1811945: (b)(4) items manufactured and released on 11-mar-2019.Expiration date: 2024-02-27.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.Clinical evaluation performed by medacta medical affairs manager: revision surgery performed 1 month after reverse total shoulder arthroplasty due to dislocation.The components remained intact and we cannot detect any hint of a defect that led to the problem.These events are normal originated by progression of disease to the soft tissues or insufficient re-establishment of soft tissue tension after the operation.No further conclusion can be drawn with the elements at hand.
Event or Problem Description
The patient came in reporting pain 1 month after the primary surgery due to a dislocation of the glenosphere from the liner.The cause of the dislocation is unknown.The surgeon revised all medacta components with competitor components.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39X24.5
• Common Device Name: SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11504339
• Report Number: 3005180920-2021-00209
• Device Sequence Number: 2843972
• Product Code: HSD
• UDI-Device Identifier: 07630040728072
• UDI-Public: 07630040728072
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2021

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: 04/24/2024
• Device Model Number: 04.01.0208
• Device Catalogue Number: 04.01.0208
• Device Lot Number: 189939
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 03/17/2021
• 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