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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 december 2022: lot 2004002: (b)(4) items manufactured and released on 25-mar-2021.Expiration date: 2026-03-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Additional components involved: reverse shoulder system 04.01.0120 humeral reverse hc liner ø36/+3mm (k170452) lot.2103236: (b)(4) items manufactured and released on 26-may-2021.Expiration date: 2026-05-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° lot.2003875: (b)(4) items manufactured and released on 25-mar-2021.Expiration date: 2026-03-16.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.
Event or Problem Description
The patient came in reporting instability due to laxity.At about 1 year and 2 months post primary the surgeon revised the 36xø24.5mm glenosphere with a 39xø24.5mm glenosphere, revised the ø36/+3mm liner with a ø39/+0mm and revised the +0mm/0° metaphysis with a +9mm/0° metaphysis.The surgery was completed successfully.

• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15994321
• Report Number: 3005180920-2022-00962
• Device Sequence Number: 5724474
• Product Code: HSD
• UDI-Device Identifier: 07630040728065
• UDI-Public: 07630040728065
• 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: 2022
• 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): 12/16/2022

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: 03/16/2023
• Device Model Number: 04.01.0207
• Device Catalogue Number: 04.01.0207
• Device Lot Number: 2004002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2021
• 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: 67 YR
• Patient Sex: Male
• Patient Race: White