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

Model Number	04.01.0208
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 september 2021: lot 189939: (b)(4) items manufactured and released on 8-may-2019.Expiration date: 2024-apr-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 2 similar reported events.Additional item involved in the event, batch review performed on 21 september 2021: reverse shoulder system 04.01.0123 humeral reverse hc liner ø39/+3mm (k170452) lot.1908972: lot 1908972: (b)(4) items manufactured and released on 7-nov-2019.Expiration date: 2024-oct-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 3 similar reported events.
Event or Problem Description
On the second day after the primary surgery, the surgeon revised the liner and the metaphysis due to instability and looseness (mdr 2021-00784).Presently, 3 weeks after the previous surgery, the patient came in due to a dislocation of the humerus from the glenosphere.The surgeon revised the baseplate, lateralized glenosphere, humeral diaphysis, reverse metaphysis, and liner.The surgery was completed successfully.).

• Brand Name: REVERSE SHOULDER SYSTEM LATERAL GLENOSPHERE 39X24.5
• Common Device Name: SHOULDER LATERAL GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12630782
• Report Number: 3005180920-2021-00808
• Device Sequence Number: 19905917
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2021

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: 09/17/2021
• Initial Report FDA Received Date: 10/14/2021
• 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