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

Model Number	04.01.0278
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 march 2022: lot 2012762: (b)(4) items manufactured and released on 18-mar-2021.Expiration date: 2026-03-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs department: suspected early infection in rsa, 2 weeks after primary operation.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.Additional items involved in the event, batch review performed on 02 march 2022: reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot.2104516.Lot 2104516: (b)(4) items manufactured and released on 22-nov-2021.Expiration date: 2026-11-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Reverse shoulder system 04.01.0119 humeral reverse hc liner ø36/+0mm (k170452) lot.2115605.Lot 2115605: (b)(4) items manufactured and released on 20-jan-2022.Expiration date: 2027-01-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
Revision surgery performed at about 2 weeks post primary for possible infection, because the wound was not closing properly.Liner, metaphysis and glenosphere revised successfully.
Event or Problem Description
Revision surgery performed at about 2 weeks post primary for infection (straphylcoccus epidermidis), because the wound was not closing properly.Liner, metaphysis and glenosphere revised successfully after wound cleaning.

• Brand Name: REVERSE SHOULDER SYSTEM SENSITIN LAT. GLENOSPHERE 36XØ24.5
• Common Device Name: LATERALIZED GLENOSPHERE SENSITIN
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13886226
• Report Number: 3005180920-2022-00199
• Device Sequence Number: 13820063
• Product Code: PHX
• UDI-Device Identifier: 07630345709004
• UDI-Public: 07630345709004
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K203755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2022
• 2 Devices were Involved in the Event: 1 2

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: 03/08/2026
• Device Model Number: 04.01.0278
• Device Catalogue Number: 04.01.0278
• Device Lot Number: 2012762
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2021
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White