MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 36XØ24.5; SHOULDER GLENOSPHERE

Model Number	04.01.0207
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 month and 2 weeks after the primary surgery, the surgeon decided to revise the inlay and the glenosphere due to a possible infection.A new glenosphere (36mm lateralized) and inlay (36/0mm) were implanted successfully.
Additional Manufacturer Narrative
Batch review performed on 11-apr-2023.Lot 2236673: (b)(4) manufactured and released on 04-nov-2022.Expiration date: 2027-10-20.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported case during the period of review.Additional device involved: batch review performed on 11-apr-2023.Reverse shoulder system 04.01.0119 humeral reverse hc liner ø36/+0mm (k170452) lot 2236051: (b)(4) manufactured and released on 20-oct-2022.Expiration date: 2027-10-04.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medacta medical affairs manager: early infection in rsa, 1 months and 2 weeks after index operation.A new glenosphere (36mm lateralized) and inlay (36/0mm) were implanted successfully.Infection is a known possible adverse event following every surgery, including rsa's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.

• Brand Name: REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 36XØ24.5
• 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: 16723119
• Report Number: 3005180920-2023-00234
• Device Sequence Number: 15251490
• Product Code: HSD
• UDI-Device Identifier: 07630040728065
• UDI-Public: 07630040728065
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 04/12/2023

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 Model Number: 04.01.0207
• Device Catalogue Number: 04.01.0207
• Device Lot Number: 2236673
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2022
• 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 Age: 84 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White